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Glossary

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Active Immunity

Active Immunity is defined as a form of acquired immunity in which the body produces its own antibodies against disease-causing antigens. It is the protection from a disease as a result of previous exposure to the disease-causing infectious agent or part of the infectious agent (antigen). Active immunity can be acquired in two ways, either by contracting the disease or through vaccination

Active Pharmaceutical Ingredient (API)

Active Pharmaceutical Ingredient (API) is any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.

Active Site

Active Site is defined as a part of an enzyme where substrates bind and undergo a chemical reaction. The majority of enzymes are proteins but RNA enzymes called ribozymes also exist. The active site of an enzyme is usually found in a cleft or pocket that is lined by amino acid residues (or nucleotides in ribozymes) that participates in recognition of the substrate. Residues that directly participate in the catalytic reaction mechanism are called active site residues.

Actual Yield

Actual Yield is defined as the quantity of a product found to be formed in a chemical reaction (distinguished from theoretical yield) i.e. the amount of product actually isolated from a reaction. Actual product yields will always be somewhat less than theoretical, due to a variety of application factors.

Adsorption

Adsorption is defined as the adhesion of atoms, ions, biomolecules or molecules of gas, liquid, or dissolved solids to a surface because of chemical or electrical attraction - typically accomplished with granular activated carbon to remove dissolved organics and chlorine. This process creates a film of the adsorbate (the molecules or atoms being accumulated) on the surface of the adsorbent.

Adverse Drug Reaction (ADR)

Adverse Drug Reaction (ADR) is an expression that describes harm associated with the use of given medications at a normal dose. Adverse events can range from mild to severe. Serious adverse drug reactions are those that can cause disability, are life-threatening, result in hospitalization or death, or are birth defects.

Allergy

An Allergy is defined as a hypersensitive disorder of the immune system. Allergic reactions occur to normally harmless environmental substances known as allergens; these reactions are acquired, predictable, and rapid. It is characterized by excessive activation of certain white blood cells called mast cells and basophils by a type of antibody known as IgE, resulting in an extreme inflammatory response. Common allergic reactions include eczema, hives, hay fever, asthma attacks, food allergies, and reactions to the venom of stinging insects such as wasps and bees.

Amorphous Materials

Amorphous Materials, also known as soft glasses, deform and flow through a collective movement of their particles. These materials (which include chocolate mousse, shaving cream, mayonnaise, metallic glasses, granular materials and mud) are amorphous solids, in other words, they are resistant like solids but, like liquids, lack a crystalline structure. Colloids, emulsions, window glass, dense polymers, and even biological tissues are some examples.

Amorphous Solids

Amorphous Solids are solids that have a disordered atomic structure. In contrast, solids that exhibit long-range order in the atomic positions are called crystallines or morphous. Most classes of solid materials can be found or prepared in an amorphous form. For instance, common window glass is an amorphous solid, many polymers (such as polystyrene) are amorphous, and even junk foods such as cotton candy are amorphous solids.

Anti-Interferon

Anti-Interferon is an antibody to an interferon. It is used for the purification of interferons. The untoward effects of the interferons can be reversed or prevented by simultaneously adding anti-interferon (usually an antibody). This helps in treating many diseases, especially viral infections.

Antibiotic

An Antibiotic is defined as an organic substance of microbial origin (usually mold or actinomycete bacteria) that is either toxic or growth inhibiting for other organisms. Also with the advent of synthetic methods of production, a substance produced by a microorganism or a similar substance (produced wholly or partly by chemical synthesis) which, in low concentrations, inhibits the growth of other microorganisms. Penicillin, tetracycline, and erythromycin are examples of antibiotics.

Antibody

An Antibody is a modified protein molecule present in the blood serum or plasma (and other body fluids), whose activity is associated chiefly with gamma globulin. Produced by the immune system in response to exposure to a foreign substance, it is the body's protective mechanism against infection and disease. An antibody is characterized by a structure complementary to the foreign substance, the antigen that provokes its formation, and is thus capable of binding specifically to the foreign substance to neutralize it.

Antibody Production

Antibody Production, for example, is when animals produce antibodies in response to proteins or other molecules (termed immunogens) recognized as foreign by their immune system. The antibodies are secreted into the plasma by B cells that are able to interact with the immunogen. The intensity of the response is determined by several factors including the size of the immunogen molecule, its chemical characteristics, and how different it is from the animal's own proteins. Most natural immunogens are proteins. The antibody response increases with repeated exposure to the immunogen, so a series of injections at regular intervals is needed to achieve both high levels of antibody production and antibodies of high affinity.

Antigen

An Antigen is defined as any of various foreign substances such as bacteria, viruses, endotoxins, exotoxins, foreign proteins, pollen, and vaccines, whose entry into an organism induces an immune response (antibody production, lymphokine production, or both) directed specifically against that molecule. Response may be demonstrated as an increased reaction, such as hypersensitivity (usually protein or a complex of protein and polysaccharide, or occasionally a polysaccharide of high molecular weight), a circulating antibody that reacts with the antigen, or some degree of immunity to infectious disease if the antigen was a microorganism or its products.

Aseptic Packaging

Aseptic Packaging is defined as the filling of a commercially sterile product into a sterile container under aseptic conditions and hermetically sealing the containers so that reinfection is prevented. This results in a product, which is shelf-stable at ambient conditions. The term “aseptic” is derived from the Greek word “septicos” which means the absence of putrefactive micro-organisms.

Assay Development

Assay Development is a procedure in molecular biology for testing or measuring the activity of a drug or biochemical in an organism or organic sample. A quantitative assay may also measure the amount of a substance in a sample. Bioassays and immunoassays are among the many varieties of specialized biochemical assays. Other assays measure processes such as enzyme activity, antigen capture, stem cell activity, and competitive protein binding.

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Bacteria

Bacteria are any of a large group of microscopic organisms having round, rod-shaped, spiral, or filamentous unicellular or noncellular bodies that are often aggregated into colonies, are enclosed by a cell wall or membrane (prokaryotes), and lack fully differentiated nuclei. Bacteria range in size from 0.4µm to 2.0µm and may exist as free-living organisms in soil, water, organic matter, or as parasites in the live bodies of plants. Some are disease producing, but most perform necessary functions such as digestion, fermentation, and nitrification. Most of the forms are variously grouped under generic names such as: Alcaligenes, Dialister, Escherichia, Klebsiella, Kurthia, Pasteurella, Salmonella, and Shigella.

Bacterium

A Bacterium is a single celled organism with no nucleus. Typically a few micrometres in length, bacteria have a wide range of shapes, ranging from spheres to rods and spirals.

Behavioural Health

Behavioural Health, as a general concept, refers to the reciprocal relationship between human behavior, individually or socially, and the well-being of the body, mind, and spirit, whether the latter are considered individually or as an integrated whole. Behavioural Health is more commonly used to describe a field of scientific study, academic proficiency and clinical healthcare practice.

Bioassay

A Bioassay, also called biological standardisation, is a type of scientific experiment. Bioassays are typically conducted to measure the effects of a substance on a living organism and are essential in the development of new drugsand in monitoring environmental pollutants. Both are procedures by which the potency (pharmacology) or the nature of a substance is estimated by studying its effects on living matter.

Bioavailability

Bioavailability is used to describe the fraction of an administered dose of unchanged drug that reaches the systemic circulation, one of the principal pharmacokinetic properties of drugs. By definition, when a medication is administered intravenously, its bioavailability is 100%. However, when a medication is administered via other routes (such as orally), its bioavailability decreases (due to incomplete absorption and first-pass metabolism) or may vary from patient to patient (due to inter-individual variation). Bioavailability is one of the essential tools in Pharmacokinetics, as bioavailability must be considered when calculating dosages for non-intravenous routes of administration.

Biobanking

A Biobank is defined as a cryogenic storage facility used to archive biological samples for use in research and experiments collected from clinically-characterised volunteers comprising blood, induced sputum, bronchial biopsies and epithelial cells. These samples are used to develop the complex in vitro human disease models. Biobanks are maintained by institutions such as hospitals, universities, nonprofit organizations, and pharmaceutical companies.

Bioequivalency

Bioequivalency is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same. It is a scientific basis on which generic and brand name drugs are compared with one another.

Biohazard

A Biohazard is defined as an infectious agent(s), or part thereof, presenting a real or potential risk to human, other animals, or plants, directly through infection or indirectly through disruption of the environment.

Bioinformatics

Bioinformatics is defined as the science of using computer technology to gather, store, analyze and merge biological data. Expertise in bioinformatics is key to handling the enormous amounts of data produced by the Human Genome Project and other sequencing projects, and serving it out to the researchers who use the data. Advances in computer research are as important as the biology for such large scale projects.

Biological Impurities

Biological Impurities are defined as impurities resulting from living matter (bacteria, virus, algae, protozoa, microfungi) and their by-products, including pyrogens (endotoxins).

Biological Indicators

Biological Indicators are defined as resistant microorganisms placed into or on various materials to confirm that a sterilization process is effective. Biological indicators are aquatic plant and animal life that are susceptible to specific types and levels of pollutants. They may for instance be placed within a filter in order to determine if a proposed autoclave cycle is effective. After autoclave, they are removed and culture tests are performed to see if the microorganisms were killed.

Biological Reactivity Tests, In Vivo

Biological Reactivity Tests, In Vivo are designed to determine the biological response of animals to elastomerics, plastics and other polymeric material with direct or indirect patient contact, or by the injection of specific extracts prepared from the material under test. Three tests are described:

1. Systemic Injection Test - Designed to determine the systemic biological responses of animals to plastics and other polymers by the single-dose injection of specific extracts prepared from a sample.

2. Intracutaneous Test - Designed to determine the local biological responses of animals to plastics and other polymers by the single-dose injection of specific extracts prepared from a sample.

3. Implantation Test - Designed to evaluate the reaction of living tissue to the plastic and other polymers by the implantation of the sample (specimen under test) itself into animal tissue.

 

With the exception of the Implantation Test, the procedures are based on the use of extracts that, depending on the heat resistance of the material, are prepared at one of the three standard temperatures: 50°, 70°, and 121°. Therefore, the class designation of a plastic must be accompanied by an indication of the temperature of extraction e.g., IV - 121°, which represents a class IV plastic extracted at 121°).

Biologics

Biologics includes a wide range of medicinal products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins created by biological processes. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources like human, animal, or microorganism and may be produced by biotechnology methods and other technologies.

Biomanufacturing

Biomanufacturing is defined as an industrial production using scalable, validated processes that use a biological organism, or parts of a biological organism, in an unnatural manner to produce a product, as well as products designed to detect, modify, maintain and study biological organisms for use as new manufacturing agents. This uses living cells as miniature factories.

Biomarker

A Biomarker is defined as anything that can be used as an indicator of a particular disease state or some other biological state of an organism. A biomarker can be a substance that is introduced into an organism as a means to examine organ function or other aspects of health. For example, rubidium chloride is used as a radioactive isotope to evaluate perfusion of heart muscle. It can also be a substance whose detection indicates a particular disease state, for example, the presence of an antibody may indicate an infection. Biomarkers can be specific cells, molecules, or genes, gene products, enzymes, or hormones.

Biomaterials

A Biomaterial is defined as a material which is in whole or in part composed of living matter, such as polymer scaffolding perfused with cells. Biomaterials may be used as a medical device which augments or replaces natural tissue for therapeutic effect. The combination of synthetic and living material derived from stem cells could enable the repair of heart valves, bone, cartilage and other tissues by replacing or patching the damaged parts with materials that are genetically identical to the patient, and therefore safe from immunological rejection.

Biometrics

Biometrics are defined as methods for uniquely recognising humans based upon one or more intrinsic physical or behavioral traits. In computer science, in particular, biometrics are used as a form of identity access management and access control. Biometrics are also used to identify individuals in groups that are under surveillance.

Biopatents

Biopatents, also referred to as patents of life, are defined as patents of living organisms that can include plant and animal species, and related biological and biotechnology-enabled inventions. These are patents on living things. They are an extreme form of control over life as they give total ownership of a patented organism for 20 years.

Biopharmaceuticals

Biopharmaceuticals, also referred to as The Biopharma Industry, is the industry where ethical pharmaceutical drugs are derived through bioprocessing. They are proteins (including antibodies), nucleic acids (DNA, RNA or antisense oligonucleotides) used for therapeutic or in vivo diagnostic purposes, and are produced by means other than direct extraction from a native (non-engineered) biological source. The first such substance approved for therapeutic use was biosynthetic 'human' insulin made via recombinant DNA technology.

Bioprocess Engineering

Bioprocess Engineering is defined as the process that uses complete living cells or their components (e.g., enzymes, chloroplasts) to effect desired physical or chemical changes. Bioprocess Engineering deals with the design and development of equipment and processes for the manufacturing of products such as food, feed, pharmaceuticals, nutraceuticals, chemicals, and polymers and paper from biological materials.

Bioprocessing

Bioprocessing is defined as any process that uses complete living cells or their components (e.g., bacteria, enzymes, chloroplasts) to obtain desired products. Bioprocessing is also key to several emerging industries and technologies, including the production of renewable biofuels such as ethanol and biodiesel, therapeutic stem cells, gene therapy vectors, and new vaccines. The Food and Drug Administration imposes stringent regulations on bioprocessing in the biotech industry; this highly regulated environment has an enormous impact on plant operations and product manufacture.

Bioreactor

A Bioreactor is defined as a closed system used for bioprocessing (flask, roller bottle, tank, vessel, or other container), which supports the growth of cells, mammalian or bacterial, in a culture medium. A bacterial reaction usually is said to take place in a fermenter, and cell culture in a bioreactor.

Biosimilars

Biosimilars, also referred to as Follow-on Biologics, is a term used to describe officially-approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. Biosimilars are also referred to as subsequent entry biologics (SEBs) in Canada. Similar biological medicinal products are often called biosimilars.

Biosynthesis

Biosynthesis, also referred to as biogenesis, is an enzyme-catalyzed process in cells of living organisms by which substrates are converted to more complex products. The biosynthesis process often consists of several enzymatic steps in which the product of one step is used as substrate in the following step. Examples for such multi-step biosynthetic pathways are those for the production of amino acids, fatty acids, and natural products. Biosynthesis plays a major role in all cells, and many dedicated metabolic routes combined constitute general metabolism.

Biotech Blog

Biotech Blogs, or biotechnology blogs, are designed for people working in the pharmaceutical and biotechnology industries. These blogs include technical articles, articles on companies in the industry, information on potential collaborations, and alliances and employment opportunities and also provide commercial, legal, political and scientific trends in biotechnology.

Biotechnology

Biotechnology Definition: Biotechnology is a field of applied biology that involves the use of living organisms and bioprocesses in engineering, technology, medicine and other fields requiring bioproducts. In modern use, similar terms include genetic engineering as well as cell- and tissue culture technologies. The concept encompasses a wide range of procedures (and history) for modifying living organisms according to human purposes - going back to domestication of animals, cultivation of plants, and "improvements" to these through breeding programs that employ artificial selection and hybridisation. By comparison to biotechnology, bioengineering is generally thought of as a related field with its emphasis more on higher systems approaches (not necessarily altering or using biological materials directly) for interfacing with and utilising living things.

Bulk Handling

Bulk Handling is defined as the transferring of flammable or combustible liquids from tanks or drums into smaller containers for distribution. Solid, free-flowing materials are said to be in bulk. The handling of these materials requires that the machinery both support their weight and confine them either to a desired path of travel for continuous conveyance or within a container for handling in discrete loads. Wet or sticky materials may also be handled successfully by some of the same machines used for bulk materials. Characteristics of materials that affect the selection of equipment for bulk handling include (1) the size of component particles, (2) flowability, (3) abrasiveness, (4) corrosiveness, (5) sensitivity to contamination, and (6) general conditions such as dampness, structure, or the presence of dust or noxious fumes.

Bulk Pharmaceutical Chemical (BPC)

Bulk Pharmaceutical Chemical (BPC) is defined as a pharmaceutical product derived by chemical synthesis, in bulk form, for later dispensing, formulation or compounding, and filling in a pharmaceutical finishing facility.

C

Calorimetry

Calorimetry is defined as an analytical method that measures heat loss or gain resulting from physical or chemical changes in a sample. Differential scanning calorimetry compares the results of heating a sample to those for heating a reference material. For example, a method to measure the temperature at which the sample crystallizes, changes phases, or decomposes.

Capsule Banding

Capsule Banding is defined as sealing of capsules filled with liquids, powders or other products. It is done to seal the joint between the capsule cap and body in order to prevent leakage of liquid products; reduce oxidation of the contents of the capsule; and to minimize the odor problems associated with both solid and liquid products. Once banded, the capsule is almost impossible to open and re-close without leaving evidence of tampering.

Carcinogenicity

Carcinogenicity, or a carcinogen, is any substance, radionuclide or radiation, that is an agent directly involved in causing cancer. This may be due to the ability to damage the genome or to the disruption of cellular metabolic processes. Several radioactive substances are considered carcinogens, but their carcinogenic activity is attributed to the radiation, for example gamma rays and alpha particles, which they emit. Carcinogenicity of radiation depends of the type of radiation, type of exposure, and penetration.

Cardiology

Cardiology is the branch of medicine dealing with the structure, function and disorders of the heart. Cardiology includes diagnosis and treatment of congenital heart defects, coronary artery disease, heart failure, valvular heart disease and electrophysiology.

Cell Culture

Cell Culture refers the complex process by which cells are grown under controlled conditions. In practice, the term "cell culture" has come to refer to the culturing of cells derived from multicellular eukaryotes, especially animal cells. The historical development and methods of cell culture are closely interrelated to those of tissue culture and organ culture. There are also cultures of plants, fungi and microbes, including viruses, bacteria and protists.

Cell Lines

Cell Lines are defined as a permanently established cell culture that will proliferate indefinitely given appropriate fresh medium and space. Some species, particularly rodents, give rise to cell lines relatively easily, whereas other species do not. No cell lines have been produced from avian tissues and the establishment of cell lines from human tissue is difficult.

Centrifugation

Centrifugation is a process that involves the use of the centrifugal force for the separation of mixtures, used in industry and in laboratory settings. More-dense components of the mixture migrate away from the axis of the centrifuge, while less-dense components of the mixture migrate towards the axis. Chemists and biologists may increase the effective gravitational force on a test tube so as to more rapidly and completely cause the precipitate ("pellet") to gather on the bottom of the tube. The remaining solution is properly called the "supernate" or "supernatant liquid". The supernatant liquid is then either quickly decanted from the tube without disturbing the precipitate, or withdrawn with a Pasteur pipette. The rate of centrifugation is specified by the acceleration applied to the sample, typically measured in revolutions per minute (RPM).

Centrifuge

A centrifuge operates on the principle of centrifugal force, the inertial reaction by which a body tends to move away from a center about which it revolves. This technique is commonly used to separate solids from liquids or liquids of different densities. Centrifugal equipment is divided into two major types, sedimenters and filters.

Chief Medical Officer (CMO)

A Chief Medical Officer (CMO) is a qualified medical doctor whose specialty is in public health and in the health of communities, rather than health of individuals. The CMO is one of the six chief professional officers, one for each of six professions, who advise the government in their respective specialty.

Chromatography

Chromatography is the collective term for a set of laboratory techniques for the separation of mixtures. Chromatography involves passing a mixture dissolved in a "mobile phase" through a stationary phase, which separates the analyte to be measured from other molecules in the mixture based on differential partitioning between the mobile and stationary phases. Chromatography may be preparative or analytical. The purpose of preparative chromatography is to separate the components of a mixture for further use (and is thus a form of purification). Analytical chromatography is done normally with smaller amounts of material and is for measuring the relative proportions of analytes in a mixture.

Cleanroom

A Cleanroom is defined as an environment, typically used in manufacturing or scientific research that has a low level of environmental pollutants such as dust, airborne microbes, aerosol particles and chemical vapors. More accurately, a clean room has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size.

Clinical Data Management (CDM)

Clinical Data Management (CDM), or Clinical Data Management System (CDMS), is used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ different means to verify the entry. The most popular method is double data entry. Once the data has been screened for typographical errors, the data can be validated to check for logical errors. Another function that the CDMS can perform is the coding of data. Currently, the coding is generally centered on two areas; adverse event terms and medication names.

Clinical Design

A Clinical Design is defined as the formulation of trials and experiments in medical and epidemiological research, known as clinical trials. The strongest experimental design (the "gold standard") is the randomized design in which subjects (patients) are randomly assigned to treatment groups.

Clinical Development

Clinical Development, also called Drug Development, is a blanket term used to define the entire process of bringing a new drug or device to the market. It includes drug discovery / product development, pre-clinical research (microorganisms/animals) and clinical trials (on humans). Few people still refer to the drug development as mere preclinical development.

Clinical Outsourcing

Clinical Outsourcing is an alternative to keeping the process in-house. Clinical Outsourcing has long been a popular cost saving measure but now, more than ever, sponsors need to see real returns on their investment. The measures of success in outsourcing are clear – quicker, more cost efficient clinical trials that deliver results on time and on budget.

Clinical Research

Clinical Research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. The term clinical research refers to the entire biography of a drug from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the drug (including its efficacy and toxicity) are studied.

Clinical Research Coordinator (CRC)

A Clinical Research Coordinator (CRC) is responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of the Principal Investigator (PI). The CRC’s primary responsibility is the protection of human subjects, and other responsibilities include preparing the Institutional Review Board submission, writing the informed consent document, working with the institutional official in contract negotiations , developing a detailed cost analysis, negotiating the budget with the Sponsor (i.e. pharmaceutical company or granting agency), subject recruitment, patient care, adverse event reporting, preparing the case report form (CRF), submitting CRFs and other data to the Sponsor as necessary and study close-out.

Clinical Supply

Clinical Supply, or Clinical Trial Supply, is defined as the supply of materials required for conducting a clinical trial and this includes 24-hour collection and delivery of biological specimens (including infectious samples), investigational drugs, kits and other study materials and supplies, expertise/assistance with all permit applications including import permits, Ministry of Health authorizations, etc., customs clearance including pre-clearance whenever possible to ensure the fastest possible delivery, cold chain services including temperature-controlled packaging, supplies and expertise.

Clinical Supply Chain

A Clinical Supply Chain is the chain from raw materials right through to world-wide distribution to customers (the patient). The core of any good clinical supply chain system is a supply management system that addresses all of the nuances of clinical supplies. There are many processes of a clinical supply chain which can be accomplished internally. The key business units engaged with clinical supplies activities include: manufacturing, packaging, pharmacy, quality, regulatory, clinical and analytics.

Clinical Trial

A clinical trial, also called a clinical study or a medical trial, is conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place. Depending on the type of product and the stage of its development, investigators enrol healthy volunteers and/or patients into small pilot studies initially, followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries.

Co-Crystals

Co-Crystals are defined as a technology used to enhance solubility, stability and the IP position with respect to the development of active pharmaceutical ingredients (APIs). Exploring the co-crystallization potential around an API increases the intellectual property protection over a particular drug product; thus, reducing the risk of costly litigation and market erosion.

Coating System

Coating Systems are extensively used by pharmaceutical companies for coating solid oral dosage forms to protect against deterioration by environmental factors like sunlight, temperature variations, moisture, environmental gases etc., to facilitate swallowing, to mask taste and odor, to increase shelf-life, to enhance aesthetic appeal and brand image, to facilitate product identification during manufacture and prevent wastage during packing and handling, to provide immediate release, specific release, sustained release, controlled release and targeted drug delivery properties, to provide enteric release properties for release in the intestinal tract and to facilitate identification of oncological drugs.

Cold Chain

A cold chain, also referred to as cool chain, is a supply chain with cargo that undergoes end-to-end temperature control through transit. An unbroken cold chain is a sequence of storage efforts that maintain a given temperature range (usually within the bracket of 2 – 8 degrees) to transport a sensitive product, including the likes of pharmaceutical drugs and biological materials.

Complementary DNA (cDNA)

Complementary DNA (cDNA) is DNA synthesized from a mature mRNA template in a reaction catalyzed by the enzyme reverse transcriptase and the enzyme DNA polymerase. cDNA is often used to clone eukaryotic genes in prokaryotes. When scientists want to express a specific protein in a cell that does not normally express that protein (i.e., heterologous expression), they will transfer the cDNA that codes for the protein to the recipient cell. cDNA is also produced by retroviruses (such as HIV-1, HIV-2, Simian Immunodeficiency Virus, etc.) which is integrated into its host to create a provirus.

Compound Libraries

Compound Libraries are defined as the collections of compounds that provide a variety of chemically diverse structures that can be used to identify structure types that have affinity with pharmacological targets. The compounds include pure natural compounds, synthetic compounds and synthetically modified pure natural compounds.

Compound Management

Compound Management, also referred to as Compound Control, is defined as the management of chemical libraries, including renewal of outdated chemicals, databases containing the information, robotics often involved in fetching chemicals, and quality control of the storage environment. Compound Management is often a significant expense, as well as career for one or more individuals who manage a chemical library at a research site.

Compound Screening

Compound Screening is defined as the identification of compounds that could be promising candidates for drug development, before it advances to the more-costly stages of preclinical and clinical trials. Compound Screening is also done to identify the potential side effects caused by administration of such compound(s).

Containment

Containment is defined as the action of confining within a defined space a microbiological agent or other entity that is being cultured, stored, manipulated, transported, or destroyed in order to prevent or limit its contact with people and/or the environment. Methods to achieve containment include physical and biological barriers and inactivation using physical or chemical means.

Contamination

Contamination is defined as the undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material, intermediate, or API (Active Pharmaceutical Ingredient) during production, sampling, packaging or repackaging, storage or transport.

Contract Manufacturing (CM)

Contract Manufacturing (CM) is defined as a firm that manufactures components or products for another "hiring" firm. It is a form of outsourcing. The practice of utilizing contract manufacturing relies on the manufacturer's ability to drive down the cost of production through economies of scale. It also allows the hiring company to obtain the needed components or products without needing to own and operate a factory. Many industries utilize this process, especially the aerospace, defense, computer, semiconductor, energy, medical, food manufacturing, personal care, and automotive fields.

Contract Packaging

Contract Packaging is a firm that performs all packaging functions from the simplest to the most complex and from the glamorous to the hazardous. Packaging service ranges from manual and semi-automatic to full-speed, high performance packaging lines. Other services include design, warehousing, distribution and other business services. The objectives include programs to establish strong ethical standards among contract packagers and their clients, to increase knowledge and expertise within the contract packaging industry, to improve the business reputation of firms and the professional image of individuals within the industry, and to encourage the effective use of contract packaging services.

Contract Research Organisation (CRO)

A Contract Research Organisation, also called Clinical Research Organization (CRO) is a service organization that provides support to the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical research services (for both drugs and medical devices). CROs range from large, international full service organizations to small, niche specialty groups and can offer their clients the experience of moving a new drug or device from its conception to FDA marketing approval without the drug sponsor having to maintain a staff for these services.

Crystallisation

Crystallisation (Crystallization) is defined as a unit operation through which a chemical compound, dissolved in a given solvent, precipitates under certain conditions to allow successive separation between the phases. Crystallization is therefore an aspect of precipitation, obtained through a variation of the solubility conditions of the solute in the solvent, as compared to precipitation due to chemical reaction.

Current Good Manufacturing Practices (cGMPs)

Current Good Manufacturing Practices (cGMPs) are the current accepted standards of design, operation, practice, and sanitization. These are the standard guidelines set out by the FDA to ensure drug development is carried out in safe and quality processes, to avoid contamination and ensure repeatability. The FDA is empowered to inspect drug-manufacturing plants in which drugs are processed, manufactured, packaged, and stored for compliance with these standards.

Cytotoxic

Cytotoxic is a term that refers to a compound that results in a variety of cell fates. The cells may undergo necrosis, in which they lose membrane integrity and die rapidly as a result of cell lysis. The cells can stop actively growing and dividing (a decrease in cell viability), or the cells can activate a genetic program of controlled cell death (apoptosis). Examples of toxic agents are a chemical substance, an immune cell or some types of venom (e.g. from the puff adder or brown recluse spider).

Cytotoxicity

Cytotoxicity is defined as the quality of being toxic to cells. Cytotoxicity assays are widely used by the pharmaceutical industry to screen for cytotoxicity in compound libraries. Antibody-dependent cell-mediated cytotoxicity (ADCC) describes the cell-killing ability of certain lymphocytes, which requires the target cell being marked by an antibody. Lymphocyte-mediated cytotoxicity, on the other hand, does not have to be mediated by antibodies; nor does complement-dependent cytotoxicity (CDC), which is mediated by the complement system.

D

Data Integrity

Data Integrity is defined as that data that has a complete or whole structure or in other terms the validity of data and their relationships. All characteristics of the data including business rules, rules for how pieces of data relate dates, definitions and lineage must be correct for data to be complete. For electronic records to be trustworthy and reliable, the links between raw data, metadata, and results must not be compromised or broken. Without data integrity, it is not possible to regenerate a previous result reliably.

Data Migration

Data Migration is defined as the process of translating data from one system to another when a company replaces the current computing systems with a new one. Data migration phases (design, extraction, cleansing, load, verification) for applications of moderate to high complexity are commonly repeated several times before the new system is deployed.

Dentistry

Dentistry is the branch of medicine that is involved in the evaluation, diagnosis, prevention, and surgical or non-surgical treatment of diseases, disorders and conditions of the oral cavity, maxillofacial area and the adjacent and associated structures and their impact on the human body. Dentistry is widely considered necessary for complete overall health.

Dermatology

Dermatology is the branch of medicine dealing with the structure, function and diseases of skin, a unique specialty with both medical and surgical aspects. Problems include warts, hair loss, fungal infections, acne, athlete's foot, eczema, rashes and skin cancer. A dermatologist takes care of diseases, in the widest sense, and some cosmetic problems of the skin, scalp, hair, and nails.

Disposable Medical Supplies

Disposable Medical Supplies is a firm that supplies disposable medical and lab consumables such as disposable infusion sets, blood transfusion sets, vaginal speculum, urinary swab, endometrial suction curette, cervical spatula, various catheters, syringe sets etc. Disposable Medical Supplies are designed to minimize patient discomfort and distress.

Dissolution Testing

Dissolution Testing is defined as a critical formulation tool in the process of drug discovery that entails measuring the stability of the investigational product, achieving uniformity in production lots and determining its in vivo availability. The Dissolution Testing method is useful in the pharmaceutical and biotechnology industry to formulate drug dosage forms and to develop quality control specifications for its manufacturing process.

Distillation

Distillation is defined as a method of separating mixtures based on differences in their volatilities in a boiling liquid mixture. Distillation is a unit operation, or a physical separation process, and not a chemical reaction. It is used to separate crude oil into more fractions for specific uses such as transport, power generation and heating. Water is distilled to remove impurities, such as salt from seawater. Air is distilled to separate its components—notably oxygen, nitrogen, and argon—for industrial use. Distillation of fermented solutions has been used since ancient times to produce distilled beverages with higher alcohol content. The premises where distillation is carried out, especially distillation of alcohol are known as a distillery.

DNA (Deoxyribonucleic Acid)

DNA (Deoxyribonucleic Acid) is the molecular basis for genes; every inherited characteristic has its origin somewhere in the code of the organism's complement of DNA. The code is made up of subunits, nucleic acids. The organism to produce the required proteins that compose the genetic traits of the organism and its life functions interprets the sequence of the four nucleic acids.

DNA Array

A DNA Array is defined as a multiplex technology used in molecular biology. It consists of an arrayed series of thousands of microscopic spots of DNA oligonucleotides, called features, each containing picomoles (10-12 moles) of a specific DNA sequence, known as probes (or reporters). DNA arrays can be used to measure changes in expression levels, to detect single nucleotide polymorphisms (SNPs), or to genotype or resequence mutant genomes.

DNA Sequence

A DNA Sequence is defined as the relative order of base pairs, whether in a fragment of DNA, a gene, a chromosome, or an entire genome. The DNA sequence has capacity to carry information which directs the functions of living beings, the term genetic sequence is often used. Sequences can be read from the biological raw material through DNA sequencing methods.

DNA Sequencing

DNA Sequencing refers to sequencing methods for determining the order of the nucleotide bases—adenine, guanine, cytosine, and thymine—in a molecule of DNA. Two common methods available are The Maxam Gilbert technique, which uses chemicals to cleave DNA into fragments at specific bases; or, most commonly, the Sanger technique (also called the di-deoxy or chain-terminating method) which uses DNA polymerase to make new DNA chains, in the presence of di-deoxynucleotides (chain terminators) to stop the chain randomly as it grows. In both cases, the DNA fragments are separated according to length by polyacrylamide gel electrophoresis, enabling the sequence to be read directly from the gel.

Dosage Form (DF)

Dosage Form (DF) is defined as the physical form of a dose of a chemical compound used as a drug or medication intended for administration or consumption. Common dosage forms include pill, tablet, or capsule, drink or syrup, aerosol or inhaler, liquid injection, pure powder or solid crystal (e.g., via oral ingestion or freebase smoking), and natural or herbal form such as plant or food of sorts, among many others. The route of administration (ROA) for drug delivery is dependent on the dosage form of the substance.

Dosage Group

A Dosage Group is defined as a group of subjects in a clinical trial receiving the same or different dosages (amount) of a drug being tested. For example out of 100 congestive heart failure patients, Group A (n=50) receives 50mg/day and Group B (n=50) receives 150 mg/day of losartan.

Downstream Processing

Downstream Processing refers to the recovery and purification of biosynthetic products, particularly pharmaceuticals, from natural sources such as animal or plant tissue or fermentation broth, including the recycling of salvageable components and the proper treatment and disposal of waste. It is an essential step in the manufacture of pharmaceuticals such as antibiotics, hormones (e.g. insulin and human growth hormone), antibodies (e.g. infliximab and abciximab) and vaccines; antibodies and enzymes used in diagnostics; industrial enzymes; and natural fragrance and flavor compounds. Downstream processing is usually considered a specialized field in biochemical engineering.

Drug Delivery

Drug Delivery is the method or process of administering a pharmaceutical compound to achieve a therapeutic effect in humans or animals. Drug delivery technologies are patent protected formulation technologies that modify drug release profile, absorption, distribution and elimination for the benefit of improving product efficacy and safety, as well as patient convenience and compliance. Most common routes of administration include the preferred non-invasive peroral (through the mouth), topical (skin), transmucosal (nasal, buccal/sublingual, vaginal, ocular and rectal) and inhalation routes.

Drug Delivery Systems

Drug Delivery Systems are used to deploy medications intact to specifically targeted parts of the body through a medium that can control the therapy’s administration by means of either a physiological or chemical trigger. During the past decade, polymeric microspheres, polymer micelles, and hydrogel-type materials have all been shown to be effective in enhancing drug targeting specificity, lowering systemic drug toxicity, improving treatment absorption rates, and providing protection for pharmaceuticals against biochemical degradation. In addition, several other experimental drug delivery systems show exciting signs of promise, including those composed of biodegradable polymers, dendrimers (so-called star polymers), electroactive polymers, and modified C-60 fullerenes (also known as “buckyballs”).

Drug Development Process

Drug Development Process is a precarious pharmaceutical business with risks outweighing benefits. Though risky, many major pharmaceutical companies are involved in drug development process, as it is essential for the survival of pharmaceutical companies and for the betterment of people with newer therapy for treating diseases that afflict millions of people worldwide. The full drug development process is a lengthy and complicated one taking ten to twelve years. The cost of developing a new drug is over €800 million, about 60% of which is spent on necessary rigorous clinical trials.

Drug Discovery

Drug Discovery is defined as the process by which drugs are discovered and/or designed. The process of drug discovery involves the identification of candidates, synthesis, characterization, screening, and assays for therapeutic efficacy. Once a compound has shown its value in these tests, it will begin the process of drug development prior to clinical trials. Despite advances in technology and understanding of biological systems, drug discovery is still a lengthy, "expensive, difficult, and inefficient process" with low rate of new therapeutic discovery.

Drug Manufacturing

Drug Manufacturing is defined as the process of industrial-scale synthesis of pharmaceutical drugs by pharmaceutical companies. Drug manufacturing services are characterized by a core commitment to meeting the client’s objectives with the highest quality while maintaining the most efficient use of time and controlling costs.

Drug Regulatory Affairs

Drug Regulatory Affairs refers to all aspects within the pharmaceutical development process and how they are subject to various degrees of regulation. The pharmaceutical law frame, guidelines covering Quality, Safety and Efficacy as well as Health Authorities' attitudes and requirements etc. have a great influence on the drug development process and the success of it. Regulatory affairs professionals deal with these aspects.

Drug Targets

A Drug Target is defined as a tiny molecule that is involved in some sort of process in a human cell. The process it is involved with can be anything from metabolic (having to do with metabolism) to signaling (taking a chemical signal and turning it into a physical response). Drug targets are specific to a disease condition, like the destruction of the myelin sheath with multiple sclerosis. Other drug targets are disease specific proteins, receptors, enzymes, genes, etc.

Dry Heat Sterilisation

Dry Heat Sterilisation is a sterilization method utilizing a heat oven or continuous tunnel (gas or electric heated), as opposed to steam sterilization in an autoclave, usually used for glassware and metal parts. In depyrogenation temperatures of 250ºC result in sterilization and the inactivation of endotoxin present on the surface of the equipment.

E

Efficacy

Efficacy, or intrinsic activity (IA), is defined as the relative ability of a drug-receptor complex to produce a maximum functional response. This use of the word "efficacy" was introduced by Stephenson (1956) to describe the way in which agonists vary in the response they produce, even when they occupy the same number of receptors. High efficacy agonists can produce the maximal response of the receptor system while occupying a relatively low proportion of the receptors in that system.

Elastomer

An Elastomer is defined as a long chain co-polymers or terpolymers (two or three different monomers in one chain) that contain adequate crosslinks among individual chains. Fluorinated elastomers are more stable than hydrocarbon or silicon elastomers because C-F bonds are approximately 30% stronger than C-H bonds. There are five major FDA compliant elastomers used in the pharmaceutical and biopharmaceutical industries: EPDM (ethylene-propylene-diene rubber), fluororelastomers (FKM), platinum-cured silicon (pt-Si), and finally Kalrez® parts using compounds KLR-6221 and KLR-6230, which are perfluoroelastomers.

Electronic Common Technical Document (eCTD)

Electronic Common Technical Document (eCTD) is a message specification for the transfer of files and metadata from a submitter to a receiver. The content is based on the Common Technical Document (CTD) format. It was developed by the International Conference on Harmonization (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). The eCTD has five modules: Administrative Information and Prescribing Information, Common Technical Document Summaries, Quality, Nonclinical Study Reports and Clinical Study Reports.

Electronic Laboratory Notebook (ELN)

An Electronic Laboratory Notebook (ELN), also referred to as an electronic lab notebook, is a software program designed to replace paper laboratory notebooks. Lab notebooks in general are used by scientists and technicians to document research, experiments and procedures performed in a laboratory. ELNs can be divided into two categories: “Specific ELNs" contain features designed to work with specific applications, scientific instrumentation or data types and "Cross-disciplinary ELNs" or "Generic ELNs" are designed to support access to all data and information that needs to be recorded in a lab notebook.

Electronic Record

An Electronic Record is defined as any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. Electronic record contains machine-readable rather than human-readable information.

Electronic Signature (e-sig)

An Electronic Signature (e-sig) is defined as a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature. It may be an electronic transmission of the document which contains the signature, as in the case of facsimile transmissions, or it may be encoded message, such as telegraphy using morse code.

Electrophoresis

Electrophoresis is defined as the migration of electrically charged proteins, colloids, molecules, or other particles when dissolved or suspended in an electrolyte through which an electric current is passed. The most important use of electrophoresis is in the analysis of blood proteins. Since the proportion of these proteins varies widely in different diseases, electrophoresis can be used for diagnostic purposes. Electrophoresis is used to study bacteria and viruses, nucleic acids, and some types of smaller molecules, including amino acids.

ELISA (Enzyme Linked Immunosorbent Assay)

Enzyme Linked Immunosorbent Assay (ELISA) is defined as an assay that relies on an enzymatic conversion reaction and is used to detect the presence of specific substances (such as enzymes or viruses or antibodies or bacteria). During the procedure the test material or sample is exposed to a complex of an enzyme linked to an antibody specific to the disease or substance being tested for; when the enzyme and the antigen-antibody complex bind, a color indicator or other easily recognizable sign occurs.

Emergency Medicine

Emergency Medicine is defined as a medical specialty in which a physician receives practical training to care for patients with acute illnesses or injuries which require immediate medical attention. While not usually providing long-term or continuing care, emergency medicine physicians diagnose a variety of illnesses and undertake acute interventions to stabilize the patient. Emergency medicine has evolved to treat conditions that pose a threat to life, limb, or have a significant risk of morbidity.

Enamine

Enamine is defined as an unsaturated compound derived by the reaction of an aldehyde or ketone with a secondary amine followed by loss of H2O. The word "enamine" is derived from the affix en-, used as the suffix of alkene, and the root amine. Enamines are both good nucleophiles and good bases.

Endocrinology

Endocrinology is the branch of medicine that deals with the hormone-secreting glands (ex: thyroid, pituitary, adrenal, pancreas, ovaries, testes, etc.); also deals with diabetes. Endocrinology refers to the endocrine system - a collection of hormone-producing glands which regulate the body's rate of metabolism, growth and reproductive development and functioning. An increase or decrease in production interferes with the process it controls. Examples of problems include thyroid conditions and diabetes.

Endotoxin

An Endotoxin is defined as a poisonous complex molecule (lipopolysaccharide) that forms an integral part of the bacterial (gram-negative bacteria) cell wall and is only released when the integrity of the wall is disturbed. Certain organisms may release endotoxins (e.g. E. coli) during biosynthesis of a recombinant DNA product, thus necessitating purification steps to ensure their removal. In water treatment, it most often refers to pyrogens.

Endpoint

An Endpoint is defined as the point at which an experimental animal's pain and/or distress is terminated, minimized or reduced by taking actions such as humanely killing the animal, terminating a painful procedure, or giving treatment to relieve pain and/or distress.

Enzyme

An Enzyme is defined as any of numerous proteins or conjugated proteins produced by living organisms and functioning as complex biochemical catalysts. They not only promote reactions but also function as regulators making sure the organism do not produce too much or too little of any chemical substance. Although all enzymes are proteins, many contain additional non-protein components essential for catalytic activity. Such enzymes are termed haloenzymes. The protein part of this enzyme is termed an apoenzyme and the non-amino acid part is termed a coenzyme.

Ethical Pharmaceutical

Ethical Pharmaceuticals or ethics involving pharmaceuticals, are built from the organizational ethics stemming from a drug manufacturer - system compliance, accountability and culture. The ethics formed are based on legal requirements from regulatory boards. The law however should be seen as a minimum standard and a higher ethical standard should be demanded; from pharmaceutical companies have seen these demands by both agency and public demand across the world. It is a controlled substance for the diagnosis or treatment of disease.

European Medicines Evaluation Agency (EMEA)

European Medicines Evaluation Agency (EMEA) or European Medicines Agency (EMA) is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products. The EMA was set up in 1995 with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, in an attempt to harmonize (but not replace) the work of existing national medicine regulatory bodies.

Excipient

An Excipient is defined as a more or less inert substance added in a prescription drug compound as a diluent or vehicle or to give form or consistency when the remedy is given in a pill form; simple syrup, aromatic powder, honey, and various elixirs are examples of excipients.

F

FDA Approval

FDA Approval refers to the list of drugs approved by the Food and Drug Administration (FDA) for sale in the United States. New drugs receive extensive scrutiny before FDA approval in a process called a New Drug Application or NDA. After approval of an NDA, the sponsor must review and report to the FDA every patient adverse drug experience of which it learns. Unexpected serious and fatal adverse drug events must be reported within 15 days; other events on a quarterly basis. As a condition of approval, a sponsor may be required to conduct additional clinical trials, called Phase IV trials.

FDA Compliance

FDA Compliance refers to conforming to a rule, such as a specification, policy, standard or law stated by U.S. FDA. Regulatory compliance describes the goal that corporations or public agencies aspire to in their efforts to ensure that personnel are aware of and take steps to comply with relevant laws and regulations.

Fermentation

Fermentation is defined as the biochemical synthesis of organic compounds by microorganisms. It is the process of growing microorganisms within an enclosed tank (fermenter) under controlled conditions of aeration, agitation, temperature, and pH. The different types organisms used as a basis for fermentation are: bacteria (E. coli), yeasts, molds, Chinese Hamster Ovary (CHO) cells, kidney cells and vaccines to viruses.

Fill and Finish (Parenteral Drugs)

Fill and Finish (Parenteral Drugs) refers to preparation of parenteral drugs, either LVPs or SVPs, which demand the highest level of contamination control, because the human body's normal defenses against infection are bypassed when parenteral medications are introduced either intramuscularly (I.M.) or intravenously (I.V.) directly into the body. The processing of raw materials into finished dosage forms must comply at all times with cGMPs and must be able to support process validation. Mechanical design should include HVAC Classifications considered essential to attain global regulatory acceptance. For classifications, see the ISPE® Guide for Sterile Manufacturing Facilities. The desire for increased levels of sterility assurance has led the FDA to promote the use of terminal sterilization for aseptically filled products. The FDA has stated that terminal sterilization processing is the method of choice unless the manufacturer can show that it is detrimental to the product. Terminal sterilization may be accomplished using autoclaves that apply overpressure to balance the pressures that are developed across the inside and outside of the containers. Because of product sensitivities, biologics, and blood products are not appropriate applications for terminal sterilization.

Filtration

Filtration is defined as a mechanical or physical operation which is used for the separation of solids from fluids (liquids or gases) by interposing a medium through which only the fluid can pass. Oversize solids in the fluid are retained, but the separation is not complete; solids will be contaminated with some fluid and filtrate will contain fine particles (depending on the pore size and filter thickness).

Final Bulk Product

Final Bulk Product is defined as the final drug product after chemical or biological processing and purification, ready for concentration, drying, and filling into containers prior to dispensing and final filling.

Finished Product

Finished Product is defined as the medicinal product that has undergone all stages of production, including packaging in its final container. The specifications for release of the finished product must comply with the FDA regulations. The specifications of the finished product at manufacture may be different from those of the medicinal product at expiry.

Flow Cytometry

Flow Cytometry is defined as the analysis of biological material by detection of light-absorbing or fluorescing properties of cells or subcellular fractions (i.e., chromosomes) passing in a narrow stream through a laser beam. An absorbance or fluorescence profile of the sample is produced. Automated sorting devices, used to fractionate samples, sort successive droplets of the analyzed stream into different fractions depending on the fluorescence emitted by each droplet.

Flowmeter

A Flowmeter is defined as the quantification of bulk fluid movement. There are different types of flow meters: mechanical flow meters, pressure based meters, optical flow meters, open channel flow measurement, thermal mass flow meters, vortex flow meters, electromagnetic and coriolis flow meters.

Fluorination

Fluorination is defined as the chemical reaction that incorporates a fluorine atom into a molecule; formally derived from another compound by the replacement of one or more atoms of hydrogen with fluorine.

Food and Drug Administration (FDA)

Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services. The FDA is one of the United States federal executive departments, responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.

Formulary G

Formulary G refers to a list of medicines. Traditionally, a formulary contained a collection of formulas for the compounding and testing of medication (a resource closer to what would be referred to as a pharmacopoeia today). The main function of formularies today is to specify which medicines are approved to be prescribed under a particular contract. The development of formularies is based on evaluations of efficacy, safety, and cost-effectiveness of drugs. Depending on the individual formulary, it may also contain additional clinical information, such as side effects, contraindications, and doses.

Formulation

Formulation is defined as a mixture that is prepared according to a specific procedure (called a “formula”). Formulations are made for particular applications and normally are more effective than their individual components when these are used singly. Formulations are commercially produced for drugs, cosmetics, foods, paints, coatings, cleaning agents, and many other things.

G

Gastrointestinal

Gastrointestinal and the Gastrointestinal tract refer to the stomach and intestine, and sometimes to all the structures from the mouth to the anus. The tract may also be divided into foregut, midgut, and hindgut, reflecting the embryological origin of each segment of the tract. The GI tract releases hormones as to help regulate the digestion process. These hormones include gastrin, secretin, cholecystokinin, and grehlin.

Gene

A Gene is defined as a natural unit of hereditary material that is the physical basis for the transmission of the characteristics of living organisms from one generation to another. The basic genetic material is fundamentally the same in all living organisms. It consists of deoxyribonucleic acid (DNA) in most organisms and ribonucleic acid (RNA) in certain viruses, and is usually associated in a linear arrangement that, in part, constitutes the chromosome. The average length of a gene is 1µm and thus, about one million genes could be contained in a one-meter stretch of DNA. The segment of DNA that is involved in producing a polypeptide chain, it includes regions preceding (leader) and following (trailer) the coding region as well as intervening sequences (introns) between individual coding segments (exons).

Gene Expression

Gene Expression is defined as the process by which a gene's coded information is converted into the structures present and operating in the cell. Expressed genes include those that are transcribed into mRNA and then translated into protein and those that are transcribed into RNA but not translated into protein.

Gene Family

A Gene Family is defined as a set of several similar genes, formed by duplication of a single original gene, and generally with similar biochemical functions. One such family are the genes for human haemoglobin subunits; the ten genes are in two clusters on different chromosomes, called the a-globin and ß-globin loci. Genes are categorized into families based on shared nucleotide or protein sequences. If the genes of a gene family encode proteins, the term protein family is often used in an analogous manner to gene family.

Gene Mapping

Gene Mapping refers to the determination of the relative positions of genes on a DNA molecule (chromosome or plasmid) and of the distance, in linkage units or physical units, between them. When a genome is first investigated, this map is nonexistent. The map improves with the scientific progress and is perfect when the genomic DNA sequencing of the species has been completed. Two different ways of mapping are distinguished. Genetic mapping uses classical genetic techniques to determine sequence features within a genome. Using modern molecular biology techniques for the same purpose is usually referred to as physical mapping.

Gene Marker

A Gene Marker is a gene or DNA sequence with a known location on a chromosome that can be used to identify cells, individuals or species. It can be described as a variation (which may arise due to mutation or alteration in the genomic loci) that can be observed. A genetic marker may be a short DNA sequence, such as a sequence surrounding a single base-pair change (single nucleotide polymorphism, SNP), or a long one, like minisatellites.

Gene Sequencing

Gene Sequencing refers to the determination of the sequence of bases in a DNA strand. The two most widely used methods are the chain-termination method, developed by Sanger in the mid-seventies, and the chemical method developed by Maxam & Gilbert around the same time.

Gene Silencing

Gene Silencing is a general term describing epigenetic processes of gene regulation. The term gene silencing is generally used to describe the "switching off" of a gene by a mechanism other than genetic modification. That is, a gene which would be expressed (turned on) under normal circumstances is switched off by machinery in the cell. Genes are regulated at either the transcriptional or post-transcriptional level. Transcriptional gene silencing is the result of histone modifications, creating an environment of heterochromatin around a gene that makes it inaccessible to transcriptional machinery. Post-transcriptional gene silencing is the result of mRNA of a particular gene being destroyed or blocked. The destruction of the mRNA prevents translation to form an active gene product (in most cases, a protein).

Gene Splicing

Gene Splicing refers to the enzymatic attachment of one gene or part of a gene to another. it is created through the introduction of relevant DNA into an existing organism DNA, such as the plasmids of bacteria, to code for or alter different traits for a specific purpose, such as antibiotic resistance.

Gene Therapy

Gene Therapy is defined as is the insertion of genes into an individual's cell and biological tissues to treat disease, such as cancer where deleterious mutant alleles are replaced with functional ones. Although the technology is still in its infancy, it has been used with some success. Scientific breakthroughs continue to move gene therapy toward mainstream medicine.

Generic Drugs

Generic Drugs are drugs produced and marketed under its chemical or "generic" name (e.g. acetaminophen) as opposed to "Tylenol", a brand name for the former produced by Johnson & Johnson. A generic drug can be sold only after a proprietary drug goes off patent (i.e. when the patent runs out after 17 years). There are numerous generic drug manufacturers. While generic drugs are cheaper for consumers, they still must meet the standards of GMPs as set out by the FDA.

Generic Pharmaceutical

Generic Pharmaceutical, generic drug, or generics, refers to a drug which is produced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient. According to the U.S. Food and Drug Administration (FDA), generic drugs are identical or within an acceptable bioequivalent range to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are considered (by the FDA) identical in dose, strength, route of administration, safety, efficacy, and intended use.

Genetic Analysis

Genetic Analysis can be used generally to describe methods both used in and resulting from the sciences of genetics and molecular biology, or to applications resulting from this research. Genetic analysis may be done to identify genetic/inherited disorders and also to make a differential diagnosis in certain somatic diseases such as cancer. Genetic analyses of cancer include detection of mutations, fusion genes, and DNA copy number changes. Genetic analyses include molecular technologies such as PCR, RT-PCR, DNA sequencing, and DNA microarrays, and cytogenetic methods such as karyotyping and fluoresence in situ hybridization.

Genetic Disease

A Genetic Disease, or Genetic Disorder, is an illness caused by abnormalities in genes or chromosomes. While some diseases, such as cancer, are due in part to genetic disorders, they can also be caused by environmental factors. Most disorders are quite rare and affect one person in every several thousands or millions. Some types of recessive gene disorders confer an advantage in the heterozygous state in certain environments.

Genetic Engineering

Genetic Engineering, or Genetic Modification, is the direct human manipulation of an organism's genetic material in a way that does not occur under natural conditions. It involves the use of recombinant DNA techniques, but does not include traditional animal and plant breeding or mutagenesis. Any organism that is generated using these techniques is considered to be a genetically modified organism. The first organisms genetically engineered were bacteria in 1973 and then mice in 1974.

Genome

A Genome is defined as the entirety of an organism's hereditary information. It is encoded either in DNA or, for many types of virus, in RNA. The genome includes both the genes and the non-coding sequences of the DNA. Genome does not capture the genetic diversity or the genetic polymorphism of a species.

Genome Project

A Genome Project is a scientific endeavor that ultimately aims to determine the complete genome sequence of an organism (be it an animal, a plant, a fungus, a bacterium, a protist or a virus). The genome sequence for any organism requires the DNA sequences for each of the chromosomes in an organism to be determined. For bacteria, which usually have just one chromosome, a genome project will aim to map the sequence of that chromosome. The Human Genome Project was a landmark genome project that is already having a major impact on research across the life sciences, with potential for spurring numerous medical and commercial developments.

Genomic Library

A Genomic Library refers to a population of host bacteria, each of which carries a DNA molecule that was inserted into a cloning vector, such that the collection of cloned DNA molecules represents the entire genome of the source organism. This term also represents the collection of all of the vector molecules, each carrying a piece of the chromosomal DNA of the organism, prior to the insertion of these molecules into the host cells.

Genomics

Genomics is a discipline in genetics concerning the study of the genomes of organisms. The field includes intensive efforts to determine the entire DNA sequence of organisms and fine-scale genetic mapping efforts. The field also includes studies of intragenomic phenomena such as heterosis, epistasis, pleiotropy and other interactions between loci and alleles within the genome.

Genotoxicity

Genotoxicity refers to a deleterious action on a cell's genetic material affecting its integrity. Genotoxic substances are known to be potentially mutagenic or carcinogenic, specifically those capable of causing genetic mutation and of contributing to the development of tumors. This includes both certain chemical compounds and certain types of radiation. Typical genotoxins like aromatic amines are believed to cause mutations because they are nucleophilic and form strong covalent bonds with DNA resulting with the formation of Aromatic Amine-DNA Adducts, preventing accurate replication. Genotoxins affecting sperm and eggs can pass genetic changes down to descendants who have never been exposed to the genotoxin.

Genotype

A Genotype is defined as the genetic constitution of a cell, an organism, or an individual (i.e. the specific allele makeup of the individual) usually with reference to a specific character under consideration. For instance, the human albino gene has two recessive alleles. It is generally accepted that inherited genotype, transmitted epigenetic factors, and non-hereditary environmental variation contribute to the phenotype of an individual.

Gerontology

Gerontology is the study of the social, psychological and biological aspects of aging, investigating the aging process itself (biogerontology), investigating the interface of normal ageing and age-related disease (geroscience), investigating the effects of our aging population on society, including the fiscal effects of pensions, entitlements, life and health insurance, and retirement planning and applying this knowledge to policies and programs, including a macroscopic (i.e. government planning) and microscopic (i.e. running a nursing home) perspective.

GMP Facility

A GMP Facility is a production facility or a clinical trial materials pilot plant for the manufacture of pharmaceutical products. It includes the manufacturing space, the storage warehouse for raw and finished product, and support lab areas.

GMP Training

GMP Training is designed for all scientists (managerial and laboratory) and professionals in the biotechnology, biopharmaceutical, cosmetics, pharmaceutical and agrochemicals industries, whose job function necessitates the generation, evaluation and assurance of data, from pre-clinical studies, that will be incorporated into regulatory filings with the FDA and corresponding organizations overseas. It will benefit professionals who are new to the pharmaceutical industry and also those who need refresher training. This is also useful for quality assurance and quality control managers, regulatory affairs professionals, auditors, production managers and management interested in effective compliance techniques.

Good Clinical Practice (GCP)

Good Clinical Practice (GCP) is an international quality standard that is provided by International Conference on Harmonization (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. GCP guidelines include protection of human rights as a subject in clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. GCP Guidelines include standards on how clinical trials should be conducted; define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. In the pharmaceutical industry monitors are often called Clinical Research Associates.

Good Distribution Practice (GDP)

Good Distribution Practice (GDP) deals with the guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs intended for human consumption. GDP regulates the division and movement of pharmaceutical products from the premises of the manufacturer of medicinal products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments.

Good Engineering Practice (GEP)

Good Engineering Practice (GEP) is defined as combination of standards, specifications, codes, regulatory and industrial guidelines as well as accepted engineering and design methods intended to design, construct, operate, and maintain pharmaceutical and/or biotechnology facilities taking into account not only regulatory compliance but also safety, economics, environmental protection and operability. Standards and specifications are provided by recognized sources such as established engineering and architectural contractors as well as pharmaceutical companies.

Good Manufacturing Practice (GMP)

Good Manufacturing Practice (GMP) is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation.

Gynecology

Gynecology, or from the Greek, gynaika meaning woman, is the medical practice dealing with the health of the female reproductive system (uterus, vagina, and ovaries). Literally, outside medicine, it means "the science of women". Gynecology has been considered to end at 28 weeks gestation, but practically there is no clear cut-off. Since 1st October 1992, this cut-off may be considered to occur at 24 weeks gestation in the United States, since the law and definition of abortion changed to bring it closer to the gestation at which a fetus becomes viable.

H

Haematology

Haematology is the branch of internal medicine, physiology, pathology, clinical laboratory work, and pediatrics that is concerned with the study of blood, the blood-forming organs, and blood diseases. Hematology includes the study of etiology, diagnosis, treatment, prognosis, and prevention of blood diseases.

Halogen

A Halogen is one of the chlorine group (bromine, chlorine, fluorine, iodine) of elements, all univalent; they form monobasic acids with hydrogen, and their hydroxides (fluorine forms none) are monobasic acids. The radioactive element, astatine, also belongs to the halogen group.

Halogenation

Halogenation refers to a chemical reaction that incorporates a halogen atom into a molecule. More specific descriptions exist that specify the type of halogen: fluorination, chlorination, bromination, and iodination. Several main types of halogenation exist, including: Free radical halogenation, Ketone halogenation, Electrophilic halogenation and Halogen addition reaction.

Hazardous Chemical Reaction (HCR)

A Hazardous Chemical Reaction (HCR) is defined as a reaction which generates pressure or byproducts which could cause injury, illness or harm to humans, domestic animals, livestock or wildlife. HCR can be grouped into general categories, such as: self-reactive materials (polymerizing, decomposing and rearranging), reactive with other materials (oxygen and water), mixing of two or more chemicals in an intentional chemical process. General situations involving chemical reactivity hazards include: mixing or physical processing (blending, milling and distillation), intentional chemistry (batch, semi-batch or continuous processes), transportation, storage, handling and repackaging (warehousing or tank storage) and unintentional reactions.

High Throughput Screening (HTS)

High Throughput Screening (HTS) is defined as a method for scientific experimentation especially used in drug discovery and relevant to the fields of biology and chemistry. Using robotics, data processing and control software, liquid handling devices, and sensitive detectors, High-Throughput Screening or HTS allows a researcher to quickly conduct millions of biochemical, genetic or pharmacological tests. Through this process one can rapidly identify active compounds, antibodies or genes which modulate a particular biomolecular pathway. The results of these experiments provide starting points for drug design and for understanding the interaction or role of a particular biochemical process in biology.

Hormone

A Hormone is defined as a chemical released by a cell or a gland in one part of the body that sends out messages that affect cells in other parts of the organism. Only a small amount of hormone is required to alter cell metabolism. In essence, it is a chemical messenger that transports a signal from one cell to another. All multicellular organisms produce hormones; plant hormones are also called phytohormones. Hormones in animals are often transported in the blood. Cells respond to a hormone when they express a specific receptor for that hormone. The hormone binds to the receptor protein, resulting in the activation of a signal transduction mechanism that ultimately leads to cell type-specific responses.

Human Genome Initiative

The Human Genome Initiative is the collective name for several projects begun in 1986 by Department of Energy to (1) create an ordered set of DNA segments from known chromosomal locations, (2) develop new computational methods for analyzing genetic map and DNA sequence data, and (3) develop new techniques and instruments for detecting and analyzing DNA. This DOE initiative is now known as the Human Genome Program. The national effort, led by DOE and NIH, is known as the Human Genome Project.

Hydrogenation

Hydrogenation refers to a chemical reaction between molecular hydrogen (H2) and another compound or element, usually in the presence of a catalyst. The process is commonly employed to reduce or saturate organic compounds. Hydrogenation typically constitutes the addition of pairs of hydrogen atoms to a molecule, generally an alkene. Catalysts are required for the reaction to be usable; non-catalytic hydrogenation takes place only at very high temperatures. Hydrogen adds to double and triple bonds in hydrocarbons.

I

IBC (Intermediate Bulk Container)

An Intermediate Bulk Container (IBC) is defined as a container used for transport and storage of fluids and bulk materials. The construction of the IBC container and the materials used are chosen depending on the application, i.e. there are various types available in the market: plastic composite IBC Container, steel IBC Container and stainless steel IBC Container.

Imaging

Imaging or Medical Imaging is the technique and process used to create images of the human body (or parts and function thereof) for clinical purposes (medical procedures seeking to reveal, diagnose or examine disease) or medical science (including the study of normal anatomy and physiology). Although imaging of removed organs and tissues can be performed for medical reasons, such procedures are not usually referred to as medical imaging, but rather are a part of pathology. As a discipline and in its widest sense, it is part of biological imaging and incorporates radiology (in the wider sense), nuclear medicine, investigative radiological sciences, endoscopy, (medical) thermography, medical photography and microscopy (e.g. for human pathological investigations).

Immune Response

An Immune Response is a bodily defense reaction that recognizes an invading substance (an antigen: such as a virus or fungus or bacteria or transplanted organ) and produces antibodies (humoral response) or particular types of cytotoxic lymphoid cells (cell-mediated response) specific against that antigen.

Immunoglobulin (Ig)

Immunoglobulin (Ig), also known as Antibodies, are gamma globulin proteins that are found in blood or other bodily fluids of vertebrates, and are used by the immune system to identify and neutralize foreign objects, such as bacteria and viruses. They are typically made of basic structural units—each with two large heavy chains and two small light chains—to form, for example, monomers with one unit, dimers with two units or pentamers with five units. Antibodies are produced by a kind of white blood cell called a plasma cell. Five different antibody isotypes are known in mammals, which perform different roles, and help direct the appropriate immune response for each different type of foreign object they encounter.

Immunology

Immunology is a broad branch of biomedical science that covers the study of all aspects of the immune system in all organisms. It deals with the physiological functioning of the immune system in states of both health and disease; malfunctions of the immune system in immunological disorders (autoimmune diseases, hypersensitivities, immune deficiency, transplant rejection); the physical, chemical and physiological characteristics of the components of the immune system in vitro, in situ, and in vivo.

Impurity

Impurity refers to the substances inside a confined amount of liquid, gas, or solid, which differ from the chemical composition of the material or compound. Impurities are either naturally occurring or added during synthesis of a chemical or commercial product. During production, impurities may be purposely, accidentally, inevitably, or incidentally added into the substance. The level of impurities in a material is generally defined in relative terms. Standards have been established by various organizations that attempt to define the permitted levels of various impurities in a manufactured product.

In-Process Control

In-Process Control refers to the checks performed during production in order to monitor and if necessary to adjust the process and/or to ensure that the intermediate or API (Active Pharmaceutical Ingredient) conforms to its specification.

In-vitro

In-vitro (Latin: within the glass) is a procedure performed not in a living organism but in a controlled environment, such as in a test tube or Petri dish. Many experiments in cellular biology are conducted outside of organisms or cells; because the test conditions may not correspond to the conditions inside of the organism, this may lead to results that do not correspond to the situation that arises in a living organism.

In-vivo

In-vivo (Latin for "within the living") is experimentation using a whole, living organism as opposed to a partial or dead organism, or an in vitro controlled environment. Animal testing and clinical trials are two forms of in vivo research. In vivo testing is often employed over in vitro because it is better suited for observing the overall effects of an experiment on a living subject.

Infectious Disease

An Infectious Disease is a clinically evident illness resulting from the presence of pathogenic microbial agents, including pathogenic viruses, pathogenic bacteria, fungi, protozoa, multicellular parasites, and aberrant proteins known as prions. These pathogens are able to cause disease in animals and/or plants. Infectious pathologies are also called communicable diseases or transmissible diseases due to their potential of transmission from one person or species to another by a replicating agent (as opposed to a toxin).

Insulin

Insulin is a hormone that is central to regulating fat and steroids metabolism in the body. Insulin causes cells in the liver, muscle, and fat tissue to take up glucose from the blood, storing it as glycogen in the liver and muscle. Insulin is a peptide hormone composed of 51 amino acids and has a molecular weight of 5808 Da. It is produced in the islets of Langerhans in the pancreas. Insulin’s structure varies slightly between species of animal. Insulin from animal sources differs somewhat in "strength" (in carbohydrate metabolism control effects) in humans because of those variations.

Investigational New Drug (IND) Application

Investigational New Drug (IND) Application is defined as a document filed with the FDA prior to clinical trial of a new drug. It gives a full description of the new drug, where and how is manufactured, all QC information, etc. The IND is followed by NDA (New Drug Application).

J

Jejunum

The jejunum is the second part of the small intestine in humans and most higher vertebrates, including mammals, reptiles, and birds. Its lining is specialised for the absorption by enterocytes of small nutrient molecules which have been previously digested by enzymes in the duodenum.

K

Kinase

Kinase, or Phosphotransferase, is a type of enzyme that transfers phosphate groups from high-energy donor molecules, such as adenosine triphosphate (ATP) to specific substrates. The process is referred to as phosphorylation, not to be confused with phosphorolysis, which is carried out by phosphorylases. Phosphorylation is the transfer of a phosphate group to a molecule.

L

Laboratory Informatics

Laboratory Informatics is a relatively new field that aims to expedite the exchange of laboratory data via electronic data exchange. Laboratory informatics specialists design standards and systems to support the acquisition, retrieval and communication of test results and other laboratory data. Information systems are as critical to public health laboratories as instrumentation and reagents. Public health decisions and patient treatment hinge upon the rapid delivery of test results and other public health data. Mounting threats from terrorism, global disease and natural disasters make the need for electronic data exchange even greater.

Laboratory Information Management System (LIMS)

Laboratory Information Management System or Laboratory Integration Management Solution (LIMS) is a software system used in laboratories for the integration of all laboratory software’s, instruments, and the management of samples, laboratory users, standards and other laboratory functions such as QA/QC Quality Assurance and Quality Control, sample planning, invoicing, plate management, and workflow automation. LIMS implementations may also support information gathering, decision making, calculation, review and release into the workplace and away from the office.

Licensing

Licensing is referred to as giving permission. It refers to that permission as well as to the document recording that permission. License may be granted by a party ("licensor") to another party ("licensee") as an element of an agreement between those parties. A shorthand definition of a license is "an authorization (by the licensor) to use the licensed material (by the licensee)." In particular a license may be issued by authorities, to allow an activity that would otherwise be forbidden. It may require paying a fee and/or proving a capability. The requirement may also serve to keep the authorities informed on a type of activity, and to give them the opportunity to set conditions and limitations.

Life Science

Life Science is the study of living things. The life sciences comprise all fields of science that involve the scientific study of living organisms, like plants, animals, and human beings. However, the study of behavior of organisms, such as practiced in ethology and psychology, is only included in as much as it involves a clearly biological aspect. While biology and medicine remain centerpieces of the life sciences, technological advances in molecular biology and biotechnology have led to a burgeoning of specializations and new, often interdisciplinary fields.

Lipids

Lipids are a broad group of naturally occurring molecules which includes fats, waxes, sterols, fat-soluble vitamins (such as vitamins A, D, E and K), monoglycerides, diglycerides, phospholipids, and others. The main biological functions of lipids include energy storage, as structural components of cell membranes, and as important signaling molecules.

Liposome

A Liposome is defined as an artificial phospholipid vesicle. Liposomes can be useful for the enclosure of macromolecules such as nucleic acids or, after loading with an appropriate drug. They may be used therapeutically to achieve slow release of the drug into circulation.

Localise

Localise refers to the determination of the original position (locus) of a gene or other marker on a chromosome. Locus (plural. loci) is the position on a chromosome of a gene or other chromosome marker; also, the DNA at that position. The use of locus is sometimes restricted to mean regions of DNA that are expressed.

Lyophilisation

Lyophilisation, also known as Freeze-drying or Cryodesiccation, is a dehydration process typically used to preserve a perishable material or make the material more convenient for transport. Freeze-drying works by freezing the material and then reducing the surrounding pressure and adding enough heat to allow the frozen water in the material to sublime directly from the solid phase to the gas phase.

Lyophiliser

Lyophiliser, also referred to as Freeze Dryer, is the equipment used to freeze dry the products. Freeze drying involves the removal of water or other solvents from a frozen product. Freeze dryers carry out three steps for this process - prefreezing, primary drying and finally secondary drying. Freeze drying has been used in a number of applications however it is most commonly used in the pharmaceutical industry, for example stabilization of living material such as microbial cultures, preservation of animal specimens and the concentration and recovery of reaction products.

M

Mab (Monoclonal Antibody)

Monoclonal Antibodies (Mab) are defined as antibodies derived from a single source or clone of cells that recognize only one type of antigen. They are produced from hybridomas formed by the hybridization of two cells: a single antibody-producing cell and a cell that can be grown indefinitely in culture. Monoclonal antibodies have found markets in diagnostic kits and show potential for use in drugs and industrial purification processes.

Manufacturing Process (Biotechnology)

The Manufacturing Process in Biotechnology refers to all manufacturing and storage steps in the creation of the finished product from the weighing of components through the storing, packaging, and labeling of the finished product, including, but not limited to, the following: Mixing, granulating, milling, molding, formulating, lyophilizing, tableting, encapsulating, coating, sterilizing, and filling.

Medical and Healthcare Products Regulatory Agency (MHRA)

Medical and Healthcare Products Regulatory Agency (MHRA) is the UK regulatory authority, a government agency, for medicines and medical devices. The MHRA is responsible for the regulation of medicines and medical devices and equipment used in healthcare and the investigation of harmful incidents. The MHRA also looks after blood and blood products, working with UK blood services, healthcare providers, and other relevant organizations to improve blood quality and safety.

Medical Device

The term Medical Device refers to any health care product that does not achieve its principal intended purposes by chemical action in or on the body or by being metabolized. The term "devices" also includes components, parts, or accessories of medical devices, diagnostic aids such as reagents, antibiotic sensitivity disks, and test kits for in vitro diagnosis of diseases and other conditions. There are three classes of medical devices: Class I (General Controls which include registration of manufacturers, recordkeeping and labeling requirements, compliance with GMPs), Class II (Special Controls which includes performance standards, post market surveillance, and patient registries) and Class III (Premarket Approval which includes implanted and life supporting or life sustaining devices).

Metabolic Diseases

Metabolic Diseases, also referred to as inborn errors of metabolism, congenital metabolic diseases or inherited metabolic diseases comprise a large class of genetic diseases involving disorders of metabolism. The majority are due to defects of single genes that code for enzymes that facilitate conversion of various substances (substrates) into others (products). In most of the disorders, problems arise due to accumulation of substances which are toxic or interfere with normal function, or to the effects of reduced ability to synthesize essential compounds.

Methods Development

Methods Development is required for herbal products, new process and reactions, new molecules, active ingredients, residues, impurity profiling and component of interest in different matrices. Method development consists of techniques, methods, procedures and protocols. Method development starts with the choice of technique and efficient method development requires expert knowledge and extensive practical experience.

Microarrays

Microarrays are defined as plates or slides dotted with a grid of individual DNAs, cDNAs, or gene-specific, single-stranded sequence (oligonucleotide) that assays large amounts of biological material using high-throughput screening methods. Types of microarrays include: DNA microarrays, MMChips, Protein microarrays, Tissue microarrays, Cellular microarrays (also called transfection microarrays), Chemical compound microarrays, Antibody microarrays and Carbohydrate arrays (glycoarrays).

Microbial Barrier

A Microbial Barrier, or Microbiological Barrier, prevents the migration of microbial contaminants. The tests used with microbiological barrier systems include air sampling, surface sampling, filter and air incinerator testing, and gas-tightness testing. Microbiological barrier systems can be classified according to purpose, size, and degree of containment. Sterilization and decontamination agents are used with barrier systems for initial or terminal treatment, for the treatment of supplies and equipment moved in or out of the system, and for the maintenance of its microbiological state during use.

Microscopy

Microscopy is the technical field of using microscopes to view samples and objects that cannot be seen with the unaided eye (objects that are not within the resolution range of the normal eye). There are three well-known branches of microscopy, optical, electron, and scanning probe microscopy. Optical and electron microscopy involve the diffraction, reflection, or refraction of electromagnetic radiation/electron beams interacting with the specimen, and the subsequent collection of this scattered radiation or another signal in order to create an image. Scanning probe microscopy involves the interaction of a scanning probe with the surface of the object of interest.

Molecular Diagnostics

Molecular Diagnostics refers to the measurement of DNA, RNA, proteins or metabolites to detect genotypes, mutations or biochemical changes. This offers a uniquely broad menu of diagnostic and research assays in the areas of virology, blood screening, women's health, microbiology and genomics, and oncology.

Musculoskeletal System

The Musculoskeletal system, also known as the locomotor system, is an organ system that gives animals (including humans) the ability to move using the muscular and skeletal systems. The musculoskeletal system provides form, support, stability, and movement to the body. It is made up of the body's bones (the skeleton), muscles, cartilage, tendons, ligaments, joints, and other connective tissue. The musculoskeletal system's primary functions include supporting the body, allowing motion, and protecting vital organs. The skeletal portion of the system serves as the main storage system for calcium and phosphorus and contains critical components of the hematopoietic system.

Mutagenesis

Mutagenesis is defined as the induction of mutation in the genetic material of an organism; researchers may use physical or chemical means to cause mutations that improve the production of capabilities of organisms. There are the following types of mutagenesis: Directed mutagenesis, Insertional mutagenesis, PCR mutagenesis, Signature tagged mutagenesis, Site-directed mutagenesis and Transposon mutagenesis.

N

Nanotechnology

Nanotechnology, also referred to as "nanotech", is the study of the controlling of matter on an atomic and molecular scale. It deals with structures sized between 1 to 100 nanometer in at least one dimension, and involves developing materials or devices within that size. Nanotechnology is very diverse, ranging from extensions of conventional device physics to completely new approaches based upon molecular self-assembly, from developing new materials with dimensions on the nanoscale to investigating whether we can directly control matter on the atomic scale.

Neonatology

Neonatology is a subspecialty of pediatrics that consists of the medical care of newborn infants, especially the ill or premature newborn infant. It is a hospital-based specialty, and is usually practiced in neonatal intensive care units (NICUs). The principal patients of neonatologists are newborn infants who are ill or requiring special medical care due to prematurity, low birth weight, intrauterine growth retardation, congenital malformations (birth defects), sepsis, or birth asphyxias.

Nephrology

Nephrology is defined as the branch of medicine concerned with the development, anatomy, physiology and disorders of the kidney. Nephrology concerns the diagnosis and treatment of kidney diseases, including electrolyte disturbances and hypertension, and the care of those requiring renal replacement therapy, including dialysis and renal transplant patients.

Neurology

Neurology is a medical specialty dealing with disorders of the nervous system. Specifically, it deals with the diagnosis and treatment of all categories of disease involving the central, peripheral, and autonomic nervous systems, including their coverings, blood vessels, and all effectors tissue, such as muscle. The corresponding surgical specialty is neurosurgery. A neurologist is a physician who specializes in neurology, and is trained to investigate, or diagnose and treat neurological disorders. Pediatric neurologists treat neurological disease in children. Neurologists may also be involved in clinical research, clinical trials, as well as basic research and translational research.

Nucleic Acid

Nucleic Acid is a macromolecule composed of chains of monomeric nucleotides. In biochemistry these molecules carry genetic information or form structures within cells. The most common nucleic acids are deoxyribonucleic acid (DNA) and ribonucleic acid (RNA). Nucleic acids are universal in living things, as they are found in all cells and viruses. Artificial nucleic acids include peptide nucleic acid (PNA), Morpholino and locked nucleic acid (LNA), as well as glycol nucleic acid (GNA) and threose nucleic acid (TNA).

O

Obstetrics

Obstetrics is the surgical specialty dealing with the care of women and their children during pregnancy (prenatal period), childbirth and the postnatal period. Midwifery is the non-surgical equivalent. Veterinary obstetrics is the same concept for veterinary medicine. Almost all modern obstetricians are also gynecologists.

Oligonucleotide

An Oligonucleotide is a short nucleic acid polymer, typically with twenty or fewer bases. Although they can be formed by bond cleavage of longer segments, they are now more commonly synthesized by polymerizing individual nucleotide precursors. Automated synthesizers allow the synthesis of oligonucleotides up to 160 to 200 bases. The length of the oligonucleotide is usually denoted by "mer". Because oligonucleotides readily bind to their respective complementary nucleotide, they are often used as probes for detecting DNA or RNA.

OMICS

OMICS refers to a field of study in biology ending in -omics, such as genomics or proteomics. The related suffix -ome is used to address the objects of study of such fields, such as the genome or proteome, respectively. Many “omes” beyond the original “genome” have become useful and have been widely adopted by research scientists. “Proteomics” has become well-established as a term for studying proteins at a large scale. "Omes" can provide an easy short-hand to encapsulate a field; for example, an interactomics study is clearly recognizable as relating to large-scale analyses of gene-gene, protein-protein, or protein-ligand interactions.

Oncology

Oncology is the branch of medicine that deals with tumors (cancer). A medical professional who practices oncology is an oncologist. Oncology is concerned with: the diagnosis of any cancer in a person, therapy (e.g., surgery, chemotherapy, radiotherapy and other modalities), follow-up of cancer patients after successful treatment, palliative care of patients with terminal malignancies, ethical questions surrounding cancer care, screening efforts of the relatives of patients (in types of cancer that are thought to have a hereditary basis, such as breast cancer).

Ophthalmology

Opthalmology is the branch of medicine which deals with the anatomy, physiology and diseases of the eye. The term ophthalmologist refers to a specialist in medical and surgical eye problems. The word ophthalmology comes from the Greek roots ophthalmos meaning eye and logos meaning word, thought, or discourse; ophthalmology literally means "the science of eyes".

Oral

Oral refers to the mouth. In medical terms, oral means administration of drugs by mouth through the alimentary tract. Oral drugs are can be prescribed to be taken at different intervals, either before or after food. They can be in either liquid or solid form.

Oral Solid Dosage (OSD) Drug

Oral Solid Dosage (OSD) Drug facilities producing tablets and capsules use well defined unit operations, regardless of differences in production volumes or usage of such facilities for single or multiple product manufacture. The contents of such facility typically include warehousing with receipt and dispatch areas, clean process rooms, clean support process areas for quick turnaround without unacceptable risk of product exposure, (i.e., dust and cross-contamination).

Otolaryngology

Otolaryngology, also referred to as ENT (ear, nose and throat) is the branch of medicine and surgery that specializes in the diagnosis and treatment of ear, nose, throat, and head and neck disorders. The full name of the specialty is otolaryngology-head and neck surgery. Practitioners are called otolaryngologists-head and neck surgeons, or sometimes otorhinolaryngologists (ORL). Otolaryngology is one of the most competitive specialties to enter for physicians.

Oxidiser

An Oxidiser, also referred to as an oxidizing agent, oxidant, or oxidiser can be defined as either a chemical compound that readily transfers oxygen atoms, or a substance that gains electrons in a redox chemical reaction. In both cases, the oxidizing agent becomes reduced in the process. Because the process of oxidation is so widespread (explosives, chemical synthesis, corrosion), the term oxidizing agent has acquired multiple meanings.

P

Paediatric

Paediatric refers to the branch of medicine that deals with the medical care of infants, children, and adolescents. The age limit of such patients ranges from birth to 18. In countries where the age of majority is 18, this age limit may be from birth to age 17 (such as in Canada). A medical practitioner who specializes in this area is known as a pediatrician.

Pandemic Disease

A Pandemic Disease is an epidemic of infectious disease that is spreading through human populations across a large region; for instance a continent, or even worldwide. A widespread endemic disease that is stable in terms of how many people are getting sick from it is not a pandemic. Further, flu pandemics exclude seasonal flu, unless the flu of the season is a pandemic. Throughout history there have been a number of pandemics, such as smallpox and tuberculosis. More recent pandemics include the HIV pandemic and the 2009 flu pandemic.

Parenteral

Parenteral refers to a route of administration that involves piercing the skin or mucous membrane. The desired effect is systemic in parenteral administration. Different types of parenteral administration are intravenous (i.v.), intra-arterial (i.a.), intraosseous infusion (into the bone marrow) and intramuscular (i.m.).

Parenteral Drug (LVP, SVP)

A Parenteral Drug (LVP, SVP) is defined as one intended for injection through the skin or other external boundary tissue, rather than through the alimentary canal, so that active substances they contain are administered, using gravity or force, directly into a blood vessel, organ, tissue, or lesion. They are infused when administered intravenously (IV), or injected when administered intramuscularly (IM), or subcutaneously into the human body. A large volume parenteral (LVP) is a unit dose container of greater than 100ml that is terminally sterilized by heat. Small volume parenteral (SVP) is a "catch-all" for all non-LVP parenterals products except biologicals.

Parenteral Drug (LVP, SVP)

A Parenteral Drug (LVP, SVP) is defined as one intended for injection through the skin or other external boundary tissue, rather than through the alimentary canal, so that active substances they contain are administered, using gravity or force, directly into a blood vessel, organ, tissue, or lesion. They are infused when administered intravenously (IV), or injected when administered intramuscularly (IM), or subcutaneously into the human body. A large volume parenteral (LVP) is a unit dose container of greater than 100ml that is terminally sterilized by heat. Small volume parenteral (SVP) is a "catch-all" for all non-LVP parenterals products except biologicals.

PAT

PAT (Process Analytical Technology) is a process by which you can apply different tools alongside the production line to assess a given set of measurables – i.e quantity of a particular compound and quality of it.

Patents

Patents are defined as a set of exclusive rights granted by a state (national government) to an inventor or their assignee for a limited period of time in exchange for a public disclosure of an invention. The procedure for granting patents, the requirements placed on the patentee, and the extent of the exclusive rights vary widely between countries according to national laws and international agreements. Typically, however, a patent application must include one or more claims defining the invention which must be new, non-obvious, and useful or industrially applicable. The exclusive right granted to a patentee in most countries is the right to prevent others from making, using, selling, or distributing the patented invention without permission.

Patient Safety

Patient Safety is a new healthcare discipline that emphasizes the reporting, analysis, and prevention of medical error that often lead to adverse healthcare events. Patient safety has emerged as a distinct healthcare discipline supported by an immature yet developing scientific framework. There is a significant transdisciplinary body of theoretical and research literature that informs the science of patient safety. The resulting patient safety knowledge continually informs improvement efforts such as: applying lessons learned from business and industry, adopting innovative technologies, educating providers and consumers, enhancing error reporting systems, and developing new economic incentives.

Peptides

Peptides are short polymers of amino acids linked by peptide bonds. They have the same chemical structure as proteins, but are shorter in length. Major classes of peptides are milk peptides, ribosomal peptides, non-ribosomal peptides, peptones and peptide fragments. Peptides have recently received prominence in molecular biology. Inhibitory peptides are also used in clinical research to examine the effects of peptides on the inhibition of cancer proteins and other diseases.

Peripheral Neuropathy

Peripheral Neuropathy is the term for damage to nerves of the peripheral nervous system, which may be caused either by diseases of the nerve or from the side-effects of systemic illness. The four cardinal patterns of peripheral neuropathy are polyneuropathy, mononeuropathy, mononeuritis multiplex and autonomic neuropathy. The most common form is (symmetrical) peripheral polyneuropathy, which mainly affects the feet and legs. The form of neuropathy may be further broken down by cause, or the size of predominant fiber involvement, i.e., large fiber or small fiber peripheral neuropathy. Frequently the cause of a neuropathy cannot be identified and it is designated idiopathic.

Pharma Packaging

Pharma Packaging is a critical parameter to guarantee the quality and preservation of a drug. Any packaging leaks can spoil the product. All Pharma Packaging Systems equipment complies with the latest cGMP requirements and is fully validated including 21CFR Part 11 compliance. All systems are supplied with full documentation including detailed machine manuals, certification, and IQ/OQ packages.

Pharma Production

Pharma Production, or pharmaceutical production, is mainly carried out on a batch basis for a number of reasons. The main reasons are normally linked to the traceability of the product, validation and regulatory issues, but others include the scale of operation, the flexibility of operation required, inventory optimization or even technology development.

Pharma Quality

Pharma Quality, or pharmaceutical quality, is a global concern. Good quality medicines must meet the official standards for strength, quality, purity, packaging, and/or labeling. The lack of reliable drug quality assurance systems in many developing countries often contributes to the devastation of diseases, particularly those that have built up resistance to traditional first-line medicines. Poor quality drugs result in serious health implications including treatment failure, adverse effects, increased morbidity, mortality, development of drug resistance, and wasted resources.

Pharma Resources

Pharma Resources are used by the pharmaceutical companies. Pharmaceutical raw materials comprise substrates or elements that are used for manufacturing different types of drugs. Pharmaceutical excipients and ingredients or raw materials used to manufacture drugs are extracted from different types of sources. These sources could be natural or synthetic. Recently, many of the raw materials previously derived from natural sources are being produced synthetically in part or even bio-technologically. This is so because manufacturing them artificially is economical, safer, and much quicker.

Pharma Sales Force Effectiveness (SFE)

Pharma Sales Force Effectiveness (SFE) is a difficult concept to measure, but doing so can push pharmaceutical companies past today’s hurdles and into increased productivity and sales. With the ever increasing pressure to ensure maximum return on investment, sales force effectiveness (SFE) is becoming a high priority area in the global pharmaceutical industry.

Pharmaceutical Development

Pharmaceutical Development refers to the design of a quality product and its manufacturing process to consistently deliver the intended performance of the product. The information and knowledge gained from pharmaceutical development studies and manufacturing experience provide scientific understanding to support the establishment of the design space, specifications, and manufacturing controls. The design and conduct of pharmaceutical development studies should be consistent with their intended scientific purpose. It should be recognized that the level of knowledge gained, and not the volume of data, provides the basis for science-based submissions and their regulatory evaluation.

Pharmaceutical Manufacturing

Pharmaceutical Manufacturing, or the Pharma Manufacturing industry, develops and produces a variety of medicinal and other health-related products that save the lives of millions of people from various diseases and permits many people suffering from illness to recover to lead productive lives. There are three main types of pharmaceutical companies: large, or mainline, pharmaceutical companies, smaller pharmaceutical companies and generic pharmaceutical companies.

Pharmaceutical Regulatory

Pharmaceutical Regulatory, also referred to as Pharma Regulatory, is a provider of expert clinical and regulatory support of all phases of global drug development. They support clinical and regulatory activities in the USA, European Union, as well as the emerging markets of Asia Pacific, Latin America, and Central and Eastern Europe. This includes regulatory support of: new chemical entity development, clinical trials, marketed products, generics, OTC products, medical devices, as well as regulatory activities related to mergers and acquisitions.

Pharmaceutical Regulatory Affairs

Pharmaceutical Regulatory Affairs, or Pharma Regulatory Affairs, refers to the professionals who maintain regulations from within the industry. The pharmaceutical industry is the most regulated of all industries. Regulatory affairs professionals are key, but perhaps overlooked, players in drug development. They are the primary communications link between the company and agencies such as FDA, and they are responsible for keeping up with the increasing scope and complexity of regulations. In the pharmaceutical industry, regulatory affairs professionals have expertise in the legal and regulatory environments, as well as in clinical research protocols.

Pharmaceutical Research

Pharmaceutical Research is innovative research spanning the entire spectrum of drug discovery, development, evaluation, and regulatory approval. Research areas include: pre-formulation; drug delivery and targeting; formulation design, engineering, and processing; pharmacokinetics, pharmacodynamics, and pharmacogenomics; molecular biopharmaceutics and drug disposition; and computational biopharmaceutics.

Pharmaceutical Sales

Pharmaceutical Sales refers to the selling of pharmaceutical products. It is a fast-paced, high-turnover business that rewards assertiveness, persistence, and knowledge. Pharmaceutical sales representatives spend most of their business time on the road, talking with pharmacists, hospital personnel, physicians, patient advocacy groups, and even retirement homes, increasing the visibility of their company’s products and the volume of their sales.

Pharmaceutical Video

Pharmaceutical Video refers to electronically capturing, recording, processing, storing, transmitting, and reconstructing a sequence of still images representing scenes in motion pertaining to pharma domain. It adds great value and can significantly leverage the existing marketing techniques. A video that demonstrates how a product works, with customer reviews, would provide solid evidence that the product can indeed solve a particular problem.

Pharmaceutics

Pharmaceutics is the discipline of pharmacy that deals with all facets of the process of turning a new chemical entity (NCE) into a medication able to be safely and effectively used by patients in the community. Pharmaceutics is the science of dosage form design. There are many chemicals with known pharmacological properties but a raw chemical is of no use to a patient. Pharmaceutics deals with the formulation of a pure drug substance into a dosage form. Branches of pharmaceutics include: Pharmacokinetics, Pharmacodynamics, Pharmacoepidemiology, Pharmacogenomics, Pharmacovigilance, Pharmaceutical formulation and Pharmaceutical technology.

Pharmacology

Pharmacology is the branch of medicine and biology concerned with the study of drug action. More specifically, it is the study of the interactions that occur between a living organism and chemicals that affect normal or abnormal biochemical function. The field encompasses drug composition and properties, interactions, toxicology, therapy, and medical applications and antipathogenic capabilities. The two main areas of pharmacology are pharmacodynamics and pharmacokinetics.

Pharmacovigilance

Pharmacovigilance (PV or PhV) is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines. It is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to: identifying new information about hazards associated with medicines and preventing harm to patients.

Phase I Clinical Trials

Phase I Clinical Trials are the first stage of testing in human subjects. Normally, a small (20-100) group of healthy volunteers will be selected. This phase includes trials designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. These trials are often conducted in an inpatient clinic, where the subject can be observed by full-time staff. The subject who receives the drug is usually observed until several half-lives of the drug have passed. Phase I trials also normally include dose-ranging, also called dose escalation, studies so that the appropriate dose for therapeutic use can be found. The tested range of doses will usually be a fraction of the dose that causes harm in animal testing. Phase I trials most often include healthy volunteers.

Phase II Clinical Trials

Phase II Clinical Trials occur once the initial safety of the study drug has been confirmed in Phase I trials. Phase II trials are performed on larger groups (20-300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. Phase II studies are sometimes divided into Phase IIA and Phase IIB. Phase IIA is specifically designed to assess dosing requirements (how much drug should be given). Phase IIB is specifically designed to study efficacy (how well the drug works at the prescribed dose(s)). Some trials combine Phase I and Phase II, and test both efficacy and toxicity.

Phase III Clinical Trials

Phase III Clinical Trials are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment. Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions. Most drugs undergoing Phase III clinical trials can be marketed under FDA norms with proper recommendations and guidelines, but in case of any adverse effects being reported anywhere, the drugs need to be recalled immediately from the market. While most pharmaceutical companies refrain from this practice, it is not abnormal to see many drugs undergoing Phase III clinical trials in the market.

Phase IV Clinical Trials

Phase IV Clinical Trials are also known as Post Marketing Surveillance Trial. Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold. Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive (finding a new market for the drug) or other reasons (for example, the drug may not have been tested for interactions with other drugs, or on certain population groups such as pregnant women, who are unlikely to subject themselves to trials). The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials. Harmful effects discovered by Phase IV trials may result in a drug being no longer sold, or restricted to certain uses: recent examples involve cerivastatin (brand names Baycol and Lipobay), troglitazone (Rezulin) and rofecoxib (Vioxx).

Polymerase Chain Reaction (PCR)

Polymerase Chain Reaction (PCR) is a scientific technique in molecular biology to amplify a single or a few copies of a piece of DNA across several orders of magnitude, generating thousands to millions of copies of a particular DNA sequence. The method relies on thermal cycling, consisting of cycles of repeated heating and cooling of the reaction for DNA melting and enzymatic replication of the DNA. As PCR progresses, the DNA generated is itself used as a template for replication, setting in motion a chain reaction in which the DNA template is exponentially amplified.

Polymorph

Polymorphism is the ability of a compound to exist in more than one crystal form- or polymorph.

Polypropylene

Polypropylene (PP), also known as polypropene, is a thermoplastic polymer, made by the chemical industry and used in a wide variety of applications, including packaging, textiles (e.g. ropes, thermal underwear and carpets), stationery, plastic parts and reusable containers of various types, laboratory equipment, loudspeakers, automotive components, and polymer banknotes. An addition polymer made from the monomer propylene, it is rugged and unusually resistant to many chemical solvents, bases and acids.

Preclinical Studies

Preclinical Studies refers to the rigorous testing and evaluation stage after a compound has been identified as promising. This stage is designed to assess the chemical properties of the new drug as well as to determine the steps for synthesis and purification. In this stage, the toxicity and pharmacological effects of the drug are evaluated through in vitro and in vivo animal testing. These studies are both short and long-term. Typically, the drug is tested in a rodent and non-rodent because a drug may affect different species in different ways.

Process Analytical Technology (PAT)

Process Analytical Technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters (CPP) which affect Critical Quality Attributes (CQA). The concept actually aims at understanding the processes by defining their CPP's, and accordingly monitoring them in a timely manner (preferably in-line or on-line) and thus being more efficient in testing while at the same time reducing over-processing, enhancing consistency and minimizing rejects.

Process Automation

Process Automation includes objectives of control and also those of enterprise management. This requires an integrated approach to plant operations and enables a variety of applications such as production scheduling, inventory control, performance monitoring, statistical process control, maintenance management and environmental audit.

Process Monitoring

Process Monitoring refers to the collection of information on the use of inputs, the progress of activities, and the way these are carried out. Process monitoring looks at why and how things have happened; it looks at relevance, effectiveness and the efficiency of processes. It involves stakeholders and beneficiaries in planning, in deciding what is to be monitored, and in developing and recording monitoring processes. Process monitoring requires documentation of how the process was carried out.

Process Validation

Process Validation is defined as establishing, through documented evidence, a high degree of assurance that a specific process will consistently produce a product that meets its predetermined specifications and quality characteristics.

Process Validation Protocol

Process Validation Protocol is defined as a documented plan for testing a pharmaceutical product and process to confirm that the production process used to manufacture the product performs as intended. This includes a review of process variables and operational limitations as well as providing the sampling plan under actual use conditions.

Production

Production is defined as the production of the drugs or chemicals in a pharmaceutical preparation that exert an effect pharmacologically. This includes all operations involved in the preparation of an API (Active Pharmaceutical Ingredient), from receipt of materials, through processing and packaging, to its completion as a finished API.

Protein Expression and Production

Protein Expression and Production is a subcomponent of gene expression. It consists of the stages after DNA has been translated into polypeptide chains, which are ultimately folded into proteins. Protein expression is commonly used by proteomics researchers to denote the measurement of the presence and abundance of one or more proteins in a particular cell or tissue. Protein expression systems are very widely used in the life sciences, biotechnology and medicine. There are also significant medical applications for expression systems, notably the production of human insulin to treat diabetes.

Proteomics

Proteomics is a concept more than a defined technology. Proteomics refers to any protein-based approach that has the capacity to provide new information about proteins on a genome wide scale. 75% of the predicted proteins in multicellular organisms have no known cellular function.

Psychiatry

Psychiatry is the medical specialty devoted to the study and treatment of mental disorders—which include various affective, behavioral, cognitive and perceptual disorders. A medical doctor specializing in psychiatry is a psychiatrist. Psychiatric treatment applies a variety of modalities, including medication, psychotherapy and a wide range of other techniques such as transcranial magnetic stimulation. Treatment may be as an inpatient or outpatient, according to severity of function impairment/the disorder in question.

Pulmonary

The Pulmonary (The lung) is the essential respiration organ in all air-breathing animals, including most tetrapods, a few fish and a few snails. In mammals and the more complex life forms, the two lungs are located in the chest on either side of the heart. Their principal function is to transport oxygen from the atmosphere into the bloodstream, and to release carbon dioxide from the bloodstream into the atmosphere. This exchange of gases is accomplished in the mosaic of specialized cells that form millions of tiny, exceptionally thin-walled air sacs called alveoli. Medical terms related to the lung often begin with pulmo-, from the Latin pulmonarius, or with pneumo- (from Greek).

Purification

Purification refers to the removal of impurities of concern. The term has one meaning when applied to the preparation of drinking water, another when applied to reagent grade water for the laboratory, and still another when applied to water used to rinse ICs (Integrated Circuit devices).

Q

QA (Quality Assurance) Group

The QA (Quality Assurance) Group is the group who interprets the GMP regulations and guidelines. The responsibilities of the QA group includes: perform pharmaceutical QA oversight (auditing, analytical data and document review/approval, and regulatory compliance), perform investigations and initiate corrective action, host and facilitate client/agency audits, possess excellent time management and strong interpersonal skills and resolve problems.

QA and QC (Quality Assurance and Quality Control)

Quality Assurance and Quality Control (QA, QC) is the various process management procedures employed to preserve and enhance the quality of products or services. It is a system of procedures, checks, audits, and corrective actions used to ensure that fieldwork and laboratory analysis during the drug investigation and must meet established standards.

QBD (Quality by Design)

Quality by Design (QBD) is a concept first outlined by well-known quality expert Joseph M. Juran. Quality by Design principles have been used to advance product and process quality in every industry, and particularly the automotive industry, they have most recently been adopted by the U.S. Food and Drug Administration (FDA) as a vehicle for the transformation of how drugs are discovered, developed, and commercially manufactured.

QC (Quality Control)

QC (Quality Control) is a process by which entities review the quality of all factors involved in production. Quality control emphasizes testing of products to uncover defects, and reporting to management who make the decision to allow or deny the release, whereas quality assurance attempts to improve and stabilize production, and associated processes, to avoid, or at least minimize, issues that led to the defects in the first place.

QC (Quality Control) Group

The QC (Quality Control) Group is the group who enforces the GMP regulations. Lead the laboratories towards attainment of FDA accreditation and maintain compliance on an ongoing basis to all relevant standards. QC group will manage all aspects of raw material, bulk and finished product/stability analytical testing in the relevant laboratories (chemistry and microbiology), manage all aspects of packaging components and testing, and the QC Inspection of filling & packaging lines, implement and monitor initiatives to improve efficiency and effectiveness in the Quality Control services and delivery.

Qualification

Qualification is defined as an action of providing that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation. It is the entire process by which products are obtained from manufacturers or distributors, examined and tested, and then identified as a qualified products list.

Quality Assurance (QA)

Quality assurance, or QA for short, refers to a program for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. QA cannot absolutely guarantee the production of quality products, unfortunately, but makes this more likely. Two key principles characterize QA: "fit for purpose" and "right first time". QA includes regulation of the quality of raw materials, assemblies, products and components; services related to production; and management, production and inspection processes.

Quality Unit(s)

Quality Unit(s) are defined as an organizational unit independent of production that fulfills both Quality Assurance and Quality Control responsibilities. This may be in the form of separate QA and QC units, a single individual (or group), depending upon the size and structure of the organization.

R

Radiology

Radiology is the branch of science where scientists use x-rays to see the inside of the human body from different rays. Radiologists utilize an array of imaging technologies (such as ultrasound, computed tomography (CT), nuclear medicine, positron emission tomography (PET) and magnetic resonance imaging (MRI) to diagnose or treat diseases. Interventional radiology is the performance of medical procedures with the guidance of imaging technologies. The acquisition of medical imaging is usually carried out by the radiographer or radiologic technologist.

Reagent

A Reagent is defined as a "substance or compound that is added to a system in order to bring about a chemical reaction or is added to see if a reaction occurs". Such a reaction is used to confirm the presence of another substance. Examples of such analytical reagents include Fehling's reagent, Millon's reagent and Tollens' reagent. In organic chemistry, reagents are compounds or mixtures, usually composed of inorganic or small organic molecules that are used to affect a transformation on an organic substrate. Examples of organic reagents include the Collins reagent, Fenton's reagent, and Grignard reagent.

Recombinant Antibody

A Recombinant Antibody is defined as an antibody produced by genetic engineering. Recombinant antibody has significant advantages compared with the conventional antibody and there for its use becoming more popular now days. The fact that no animals are needed in the manufacturing procedure of the recombinant antibodies, in addition, the manufacturing time is relatively short compared with the conventional method. Moreover, the quality of the final product is higher that these of the non recombinant method.

Recombinant DNA Techniques

Recombinant DNA Techniques are the procedures that transfer genetic material between organisms or species. The basic technique of recombinant DNA involves digesting a vector DNA with a restriction enzyme, which is a molecular scissors that cuts DNA at specific sites. Recombinant DNA technology has been used for many purposes. The Human Genome Project has relied on recombinant DNA technology to generate libraries of genomic DNA molecules. Proteins for the treatment or diagnosis of disease have been produced using recombinant DNA techniques.

Recombinant DNA Technology

Recombinant DNA Technology is the procedure used to join together DNA segments in a cell-free system (an environment outside a cell or organism). Under appropriate conditions, a recombinant DNA molecule can enter a cell and replicate there, either autonomously or after it has become integrated into a cellular chromosome.

Research

Research can be defined as the search for knowledge or as any systematic investigation to establish facts. The primary purpose for applied research (as opposed to basic research) is discovering, interpreting, and the development of methods and systems for the advancement of human knowledge on a wide variety of scientific matters of our world and the universe.

Resistance (Filter)

A Resistance (Filter) is defined as the pressure drop across a filter at a stated flow and under given conditions; generally expressed in millimeters water gauge or PSI, or in SI units as N/m² or Pascals. Resistivity is the reciprocal of conductivity (R=1/C). It is a measure of specific resistance to the flow of electricity. In water, provides an easy mean of continuously measuring the purity of very low Total Dissolved Solids (TDS), or ionic concentration. The fewer the dissolved ions in water, the higher is its resistivity. Resistivity is normally expressed in Megohm-cm and is equivalent to one million ohms of resistance measured between two electrodes one centimeter apart. The theoretical maximum ionic purity of water is 18.3 Megohm-cm at 25°C.

Resolution

Resolution is defined as the subsiding or termination of an abnormal condition, such as a fever or an inflammation. It is to return from a pathological to a normal condition. Also defined as subsidence of the symptoms of a disease; especially the disappearance of inflammation without the formation of pus.

Reverse Osmosis (RO)

Reverse Osmosis (RO) is defined as the reversal of osmosis to purify water. In osmosis, water diffuses through a semi permeable membrane from a region of higher concentration (such as pure fresh water) into one of lower concentration (such as a solution of water and salt). The flow of water can be reversed with an opposing pressure that exceeds osmotic pressure. With RO, water is forced out of the lower concentrated solution (such as the salt solution), leaving the solute (impurities) behind.

Rheumatology

Rhuematology is a sub-specialty in internal medicine and pediatrics, devoted to the diagnosis and therapy of conditions and diseases affecting the joints, muscles, and bones. Clinicians who specialize in rheumatology are called rheumatologists. Rheumatologists deal mainly with clinical problems involving joints, soft tissues, certain autoimmune diseases, and the allied conditions of connective tissues. Essentially, they medically treat diseases, disorders, etc., that affect the musculoskeletal system.

RNA

Ribonucleic Acid (RNA) is a biologically important type of molecule that consists of a long chain of nucleotide units. Each nucleotide consists of a nitrogenous base, a ribose sugar, and a phosphate. RNA is single-stranded; RNA nucleotides contain ribose; and RNA has the base uracil. RNA is transcribed from DNA by enzymes called RNA polymerases and is generally further processed by other enzymes. RNA is central to protein synthesis.

S

Scale-up

A Scale-up is defined as to take a biopharmaceutical manufacturing process from the laboratory scale to a scale at which it is commercially feasible. It is to increase the size of something whilst maintaining proportion or to change a process in order to allow for greater quantities.

Sequencing

Sequencing in medicine, refers to a series of ordered consequences due to a single cause. Examples include: oligohydramnios sequence (also known as Potter sequence or Potter's syndrome or Potter's sequence) refers to the typical physical appearances of a fetus or neonate due to oligohydramnios experienced in the womb. Pierre Robin sequence also known as Pierre Robin Syndrome or Pierre Robin Malformation is a congenital condition of facial abnormalities in humans. It is not caused by a single defect gene; it is not a genetic syndrome, but rather a sequence: a chain of certain developmental malformations, one entailing the next.

Serialisation

Serialisation is defined as the act or process, physical or chemical that destroys or eliminates all viable microbes including resistant bacteria spores from a fluid or a solid. Despite being stated as an absolute, the action of sterilization is usually stated in terms of probability. Examples of sterilization methods are: steam treatment at 121°C, dry heat at 450°F, flushing with a sterilizing solution such as Hydrogen Peroxide (H2O2) or ozone (O3), irradiation, and filtration.

Single Use Technology

Single Use Technology, or limited-use technologies (also termed “disposables”) have had a transformative impact on the development and production of biopharmaceuticals. Single use technology started with the use of membrane filters, which have been in use in biopharmaceutical processing since the earliest days of the industry and their use can be traced to the mid-1970s, when the United States Food and Drug Administration required non-fiber releasing filters to be used in the production of injectables.

Solubility

Solubility is the property of a solid, liquid, or gaseous chemical substance called solute to dissolve in a liquid solvent to form a homogeneous solution of the solute in the solvent. The solubility of a substance fundamentally depends on the used solvent as well as on temperature and pressure. The extent of the solubility of a substance in a specific solvent is measured as the saturation concentration where adding more solute does not increase the concentration of the solution.

Spectrophotometry

Spectrophotometry is defined as a process in which light of known intensity and wavelength is passed through a solution and used to estimate the levels of substances dissolved in that solution. Different materials absorb light of specific wavelength and the more of that substance present, the more light of that wavelength will be absorbed. If we measure the amount of light of a particular wavelength which passes through the substance, we can calculate the amount absorbed and therefore estimate the levels of the material absorbing the light.

Spectroscopy

Spectroscopy was originally the study of the interaction between radiation and matter as a function of wavelength. Historically, spectroscopy referred to the use of visible light dispersed according to its wavelength, e.g. by a prism. Later the concept was expanded greatly to comprise any measurement of a quantity as a function of either wavelength or frequency. Thus, it also can refer to a response to an alternating field or varying frequency.

Spray Drying

Spray Drying refers to the process by which a material in suspension is converted into droplets that may be coated by a substance, either melted or dissolved in the droplet's media. The action in spray drying is primarily that of evaporation, energy is applied to the droplet forcing evaporation of the media with both energy and mass transfer through the droplet. Examples of this technology include pharmaceutical tablet granulation, and rapid drying which results in free-flowing powders on a continuous basis.

Stability Testing

Stability Testing is defined as how well a product retains its quality over the life span of the product. The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions.

Statistical Process Control (SPC)

Statistical Process Control (SPC) is defined as the application of statistical methods to the monitoring and control of a process to ensure that it operates at its full potential to produce conforming product. Under SPC, a process behaves predictably to produce as much conforming product as possible with the least possible waste. While SPC has been applied most frequently to controlling manufacturing lines, it applies equally well to any process with a measurable output. Key tools in SPC are control charts, a focus on continuous improvement and designed experiments.

Sterile Engineering Design (Fermentation)

Sterile Engineering Design, or Fermentation, is the application of techniques to prevent contamination of a fermentation process by undesirable organisms. It includes three basic phases relating to the operation of the plant. First, the fermenter with the ancillary equipment, pipe work, and valves must be brought to a sterile state. Secondly, the fermenter feed must be sterilized, and finally, sterile barriers at the interface between the fermenter and the outside environment must be maintained.

Sterile Fluid-Path Packaging

Sterile Fluid-Path Packaging is defined as the system of protective port covers and/or packaging designed to be used to ensure sterility of the portion of the medical device intended for contact with fluids. An example of sterile fluid-path packaging would be the interior of the tubing for administration of an intravenous fluid.

Sterilisation Compatibility

Sterilisation Compatibility is defined as the ability of the packaging material to both withstand the intended sterilization process and to allow attainment of the required conditions for sterilization within the final pack. Most commonly used sterilization methods are: ethylene oxide (EtO), gamma, electron-beam, steam (under controlled conditions), and plasma/hydrogen peroxide.

Syringe

A Syringe is a simple piston pump consisting of a plunger that fits tightly in a tube. The plunger can be pulled and pushed along inside a cylindrical tube (the barrel), allowing the syringe to take in and expel a liquid or gas through an orifice at the open end of the tube. The open end of the syringe may be fitted with a hypodermic needle, a nozzle, or tubing to help direct the flow into and out of the barrel. Syringes are often used to administer injections, insert intravenous drugs into the bloodstream, and apply compounds such as glue or lubricant, and measure liquids.

T

T-Cell (T-lymphocyte)

A T-Cell (T-lymphocyte) belongs to a group of white blood cells known as lymphocytes, and plays a central role in cell-mediated immunity. They can be distinguished from other lymphocyte types, such as B cells and natural killer cells (NK cells) by the presence of a special receptor on their cell surface called T cell receptors (TCR). The abbreviation T, in T cell, stands for thymus, since this is the principal organ responsible for the T cell's maturation.

Tamper-Evident Closure

Tamper-Evident Closure are typically lids for plastic and glass bottles used in the packaging and pharmaceutical industries. The closures are positioned mechanically and a seal needs to be broken in order to open them, which leaves an obvious visual indication that the bottle has been opened.

Temperature Controlled Transportation

Temperature Controlled Transportation is defined as maintaining the temperature during transportation. Temperature controlled transportation is still one of the most challenging issues within the pharmaceutical supply chain. With regulatory requirements currently under review and expected to change, the need for up-to-date cold chain logistic solutions will be paramount.

Therapeutics

Therapeutics, also referred to as therapy or treatment, is the attempted remediation of a health problem, usually following a diagnosis. Preventive therapy or prophylactic therapy is a treatment that is intended to prevent a medical condition from occurring. For example, many vaccines prevent infectious diseases. An abortive therapy is a treatment that is intended to stop a medical condition from progressing any further. A medication taken at the earliest signs of a disease, such as at the very symptoms of a migraine headache, is an abortive therapy. A supportive therapy is one that does not treat or improve the underlying condition, but instead increases the patient's comfort. Supportive treatment may be palliative care.

Tissue Culture

A Tissue Culture is defined as growing mammalian cells in the laboratory in a tissue culture medium (in vitro). For example, this allows researchers to determine the effects of various chemicals on mammalian cells without experimenting directly on live animals or man. Since a molecule of some toxic substances can harm a single mammalian cell, even one part-per-billion of some impurities can affect a tissue culture. Therefore, water used to make up tissue culture media should be extremely pure.

Titration

Titration is defined as a common laboratory method of quantitative chemical analysis that is used to determine the unknown concentration of a known reactant. Because volume measurements play a key role in titration, it is also known as volumetric analysis. A reagent, called the titrant or titrator, of a known concentration (a standard solution) and volume is used to react with a solution of the analyte or titrand, whose concentration is not known. Using a calibrated burette or chemistry pipetting syringe to add the titrant, it is possible to determine the exact amount that has been consumed when the endpoint is reached. The endpoint is the point at which the titration is complete, as determined by an indicator.

Toxicity

Toxicity is the degree to which a substance can damage an organism. Toxicity can refer to the effect on a whole organism, such as an animal, bacterium, or plant, as well as the effect on a substructure of the organism, such as a cell (cytotoxicity) or an organ (organotoxicity), such as the liver (hepatotoxicity). By extension, the word may be metaphorically used to describe toxic effects on larger and more complex groups, such as the family unit or society at large.

Toxicology

Toxicology is a branch of biology and medicine concerned with the study of the adverse effects of chemicals on living organisms. It is the study of symptoms, mechanisms, treatments and detection of poisoning, especially the poisoning of people. There are various specialized sub disciplines within the field of toxicology that concern diverse chemical and biological aspects of this area. For example, toxicogenomics involves applying molecular profiling approaches to the study of toxicology. Other areas include Aquatic toxicology, Chemical toxicology, Ecotoxicology, Environmental toxicology, Forensic toxicology, and Medical toxicology.

Trace Analysis

Trace Analysis is critical in pharmaceutical manufacturing, particularly in the equipment-cleaning steps during drug development. The analyses must be quantitative, and pass–fail levels are determined according to Food and Drug Administration guidelines and specific company policy. These analyses need an instrument that is selective, sensitive, and reliable; one that’s easy to use; and one that’s fast.

Traceability

Traceability refers to the completeness of the information about every step in a process chain. It is a prerequisite for trustworthy records, apart from data security. Traceability is the part of the laboratory data system audit trail that holds the evidence of who did what to a record and when.

Trauma

Trauma refers to a body wound or shock produced by sudden physical injury, as from accident, injury, or impact. Other definitions include: "a deeply distressing or disturbing experience", and "a physical wound or injury, such as a fracture or blow." Major trauma (defined by an Injury Severity Score of greater than 15) can result in secondary complications such as circulatory shock, respiratory failure and death. Resuscitation of a trauma patient often involves multiple management procedures. Trauma is the sixth leading cause of death worldwide, and is a serious public health problem with significant social and economic costs.

U

U.S.P. (United States Pharmacopeia)

The U.S.P. (United States Pharmcopeia) is the official pharmacopeia of the United States, published dually with the National Formulary as the USP-NF. The United States Pharmacopeial Convention (usually also called the USP) is the nonprofit organization that owns the trademark and copyright to the USP-NF and publishes it every year. Prescription and over–the–counter medicines and other health care products sold in the United States are required to follow the standards in the USP-NF. USP also sets standards for food ingredients and dietary supplements.

Ultrafiltration (UF)

Ultrafiltration (UF) is a type of filtration. Industries such as chemical and pharmaceutical manufacturing, food and beverage processing, and waste water treatment, employ ultrafiltration in order to recycle flow or add value to later products. UF's main attraction is its ability to purify, separate, and concentrate target macromolecules in continuous systems. UF does this by pressurizing the solution flow. The solvent and other dissolved components that pass through the membrane are known as permeate. The components that do not pass through are known as retentate.

Upstream Processing

Upstream Processing refers to the first step in which biomolecules are grown, usually by bacterial or mammalian cell lines, in bioreactors. When they reach the desired density (for batch and fed batch cultures) they are harvested and moved to the downstream section of the bioprocess.

Urology

Urology is the medical and surgical specialty that focuses on the urinary tracts of males and females, and on the reproductive system of males. Medical professionals specializing in the field of urology are called urologists and are trained to diagnose, treat, and manage patients with urological disorders. The organs covered by urology include the kidneys, adrenal glands, ureters, urinary bladder, urethra, and the male reproductive organs (testes, epididymis, vas deferens, seminal vesicles, prostate and penis).

V

Vaccination

A Vaccination is the administration of antigenic material (a vaccine) to produce immunity to a disease. Vaccines can prevent or ameliorate the effects of infection by many pathogens. Vaccination is generally considered to be the most effective and cost-effective method of preventing infectious diseases. The material administered can either be live but weakened forms of pathogens (bacteria or viruses), killed or inactivated forms of these pathogens, or purified material such as proteins.

Vaccine

A Vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe or its toxins. The agent stimulates the body's immune system to recognize the agent as foreign, destroy it, and "recognize" it, so that the immune system can more easily recognize and destroy any of these microorganisms that it later encounters. Vaccines can be prophylactic (e.g. to prevent or ameliorate the effects of a future infection by any natural or "wild" pathogen), or therapeutic (e.g. vaccines against cancer.

Validation

Validation is defined as a documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria.

Validation Protocol

Validation Protocol is defined as a written plan describing the process to be validated, including production equipment and how validation will be conducted. A Validation Protocol is necessary to define the specific items and activities that will constitute a cleaning validation study. It is advisable for companies to have drawn up a Master Validation plan indicating the overall Cleaning Validation strategy for the product range / equipment type / entire site.

Vascular Disease

A Vascular Disease is a form of cardiovascular disease primarily affecting the blood vessels. Vascular disease is a pathological state of large and medium sized muscular arteries and is triggered by endothelial cell dysfunction. The process causes thickening of the vessel wall, forming a plaque consisting of proliferating smooth muscle cells, macrophages and various types of lymphocytes. This plaque result in obstructed blood flow leading to diminished amounts of oxygen and nutrients that reaches the target organ. In the final stages, the plaque may also rupture causing the formation of clots, and as a result strokes.

Viral Clearance

A Viral Clearance is defined as the removal of viral contamination using specialized membranes (mostly proteins) or chromatography. In order to ensure that therapeutic drugs derived from certain sources are fully rid of any viral contamination, these protein solutions undergo viral clearance to inactivate or remove viral materials.

W

White Blood Cell (WBC)

White Blood Cells (WBCs), or leukocytes (also spelled "leucocytes"), are cells of the immune system involved in defending the body against both infectious disease and foreign materials. Leukocytes are found throughout the body, including the blood and lymphatic system. The number of WBCs in the blood is often an indicator of disease. There are normally between 4×109 and 1.1×1010 white blood cells in a liter of blood, making up approximately 1% of blood in a healthy adult. An increase in the number of leukocytes over the upper limits is called leukocytosis, and a decrease below the lower limit is called leukopenia.

Wholesaler

A Wholesaler is a person or company that sells goods. Wholesale is a middleman that buys its merchandise from a third party supplier and resells the merchandise to retail businesses or the end consumer. A wholesaler normally does not sell to other wholesalers. Wholesalers frequently physically assemble sort and grade goods in large lots, break bulk, repack and redistribute in smaller lots.

X

X Chromosome

An X Chromosome is defined as a sex chromosome that usually occurs paired in each female cell and single in each male cell. The sex chromosomes X X are one of the 23 homologous pairs of chromosomes in a female. The X chromosome spans more than 153 million base pairs (the building material of DNA) and represents about 5% of the total DNA in women's cells, 2.5% in men's.

X-ray Systems

X-Ray Systems use penetrating X-rays or gamma radiation to capture images of the internal structure of a part or finished product. The density and composition of the internal features being scanned will alter the intensity or density of the transmitted X-rays. These alterations, in turn, are captured by X-ray systems, which produce a radiographic image. X-ray systems could be used to describe a very wide range of products; items in this grouping can generally be placed into one of four groups: computer tomography systems, film based systems, X-ray generators and sources, and microfocus systems.

Y

Y Chromosome

A Y Chromosome is defined as a sex chromosome that is characteristic of male zygotes in species in which the male typically has two unlike sex chromosomes. In mammals, it contains the gene SRY, which triggers testis development if present. The human Y chromosome is composed of about 60 million base pairs. DNA in the Y chromosome is passed from father to son, thus tracking many surnames. Y-DNA analysis is thus used in family history research.

Yeast Artificial Chromosome (YAC)

A Yeast Artificial Chromosome (YAC) is a vector used to clone DNA fragments larger than 100 kb and up to 3000 kb. YACs are useful for the physical mapping of complex genomes and for the cloning of large genes. A YAC is built using an initial circular plasmid, which is typically broken into two linear molecules using restriction enzymes; DNA ligase is then used to ligate a sequence or gene of interest between the two linear molecules, forming a single large linear piece of DNA.

Z

Zeta Potential

Zeta Potential is a scientific term for electrokinetic potential in colloidal systems. The significance of zeta potential is that its value can be related to the stability of colloidal dispersions (e.g., a multivitamin syrup). The zeta potential indicates the degree of repulsion between adjacent, similarly charged particles (the vitamins) in dispersion. For molecules and particles that are small enough, a high zeta potential will confer stability, i.e., the solution or dispersion will resist aggregation. When the potential is low, attraction exceeds repulsion and the dispersion will break and flocculate. So, colloids with high zeta potential (negative or positive) are electrically stabilized while colloids with low zeta potentials tend to coagulate or flocculate.

Zoonosis

Zoonosis, or Zoonose, is any infectious disease that can be transmitted (in some instances, by a vector) from non-human animals, both wild and domestic, to humans or from humans to non-human animals (the latter is sometimes called reverse zoonosis or anthroponosis). Of the 1415 pathogens known to affect humans, 61% are zoonotic. The emergence of a pathogen into a new host species is called disease invasion.

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