Terminology
Definition
Description
Abbreviated New Drug
Products that are not new drugs but require safety and efficacy evaluation according to the regulations on the approval and review of biological products and other items.
Products that are not new drugs but require safety and efficacy evaluation according to the regulations on the approval and review of biological products and other items.
Absolute risk
The probability or chance of an event. It is usually used for the number of events (such as a disease) that occurred in a group, divided by the number of people in that group.
The probability or chance of an event. It is usually used for the number of events (such as a disease) that occurred in a group, divided by the number of people in that group.
Acceptance Criteria
Numeric limits, ranges, or other appropriate scales used to determine the acceptability of test results.
Numeric limits, ranges, or other appropriate scales used to determine the acceptability of test results.
Accreditation
The independent, third-party evaluation of a conformity assessment body (such as certification body, inspection body or laboratory) against recognised standards, conveying formal demonstration of its impartiality and competence to carry out specific conformity assessment tasks (such as certification, inspection and testing).
The independent, third-party evaluation of a conformity assessment body (such as certification body, inspection body or laboratory) against recognised standards, conveying formal demonstration of its impartiality and competence to carry out specific conformity assessment tasks (such as certification, inspection and testing).
Acellular vaccine
A vaccine containing partial cellular material as opposed to complete cells.
A vaccine containing partial cellular material as opposed to complete cells.
Acid Dissociation Constant (pKa)
The equilibrium constant of the dissociation reaction of an acid.
The equilibrium constant of the dissociation reaction of an acid.
Acquired immunity
A type of immunity that creates immunological memory after an initial response to a specific pathogen, and leads to an enhanced response to future encounters with that pathogen. Unlike the innate immune system, which is pre-programmed to react to common broad categories of pathogen, the adaptive immune system is highly specific to each particular pathogen the body has encountered. The adaptive immune system includes both humoral immunity components and cell-mediated immunity components and destroys invading pathogens. Antibodies are a critical part of the adaptive immune system. Adaptive immunity can provide long-lasting protection, sometimes for the person’s entire lifetime.
A type of immunity that creates immunological memory after an initial response to a specific pathogen, and leads to an enhanced response to future encounters with that pathogen. Unlike the innate immune system, which is pre-programmed to react to common broad categories of pathogen, the adaptive immune system is highly specific to each particular pathogen the body has encountered. The adaptive immune system includes both humoral immunity components and cell-mediated immunity components and destroys invading pathogens. Antibodies are a critical part of the adaptive immune system. Adaptive immunity can provide long-lasting protection, sometimes for the person’s entire lifetime.
Active immunity
The production of antibodies against a specific disease by the immune system. Active immunity can be acquired in two ways, either by contracting the disease or through vaccination. Active immunity is usually long-lasting, but individuals may remain susceptible to variants of the etiologic agent or to milder presentation of the disease.
The production of antibodies against a specific disease by the immune system. Active immunity can be acquired in two ways, either by contracting the disease or through vaccination. Active immunity is usually long-lasting, but individuals may remain susceptible to variants of the etiologic agent or to milder presentation of the disease.
Active Pharmaceutical Ingredients (API)
Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when so used, becomes an active ingredient of that pharmaceutical dosage form. 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.
Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when so used, becomes an active ingredient of that pharmaceutical dosage form. 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.
Actual Yield
The amount of product actually obtained from a reaction.
The amount of product actually obtained from a reaction.
Acute
Short-term, intense as in a health effect.
Short-term, intense as in a health effect.
Ad Hoc Research
Research designed for a specific purpose and specific client, and conducted as a one-off study or programme of studies.
Research designed for a specific purpose and specific client, and conducted as a one-off study or programme of studies.
Adaptive clinical trial
Type of clinical trial where the parameters and conduct of the trial for a candidate drug or vaccine may be changed based on an interim analysis.
Type of clinical trial where the parameters and conduct of the trial for a candidate drug or vaccine may be changed based on an interim analysis.
Additive Effect
The situation when the combining effects of two drugs equal the sum of the effects of the two drugs acting independently.
The situation when the combining effects of two drugs equal the sum of the effects of the two drugs acting independently.
Adjuvant
An agent added in vaccine that increases specific immune responses to an antigen.
An agent added in vaccine that increases specific immune responses to an antigen.
Adverse Drug Reaction
An appreciably harmful or unpleasant reaction resulting from an intervention related to the use of a medicinal product.
An appreciably harmful or unpleasant reaction resulting from an intervention related to the use of a medicinal product.
Adverse event
An undesirable medical condition that occurs following vaccination, which might be associated to the vaccine or its components, or which might be pure coincidence.
An undesirable medical condition that occurs following vaccination, which might be associated to the vaccine or its components, or which might be pure coincidence.
Advisory Committee on Immunization Practices (ACIP)
A group of medical and public health experts who develop recommendations on the use of vaccines in the U.S. civilian population. The recommendations stand as public health guidance for the safe use of vaccines and related biological products.
A group of medical and public health experts who develop recommendations on the use of vaccines in the U.S. civilian population. The recommendations stand as public health guidance for the safe use of vaccines and related biological products.
Affiliations
The state of being closely associated with or connected to an organization, company, etc.
The state of being closely associated with or connected to an organization, company, etc.
Affinity
A close similarity between two things, or an attraction or sympathy for someone or something, especially because of shared characteristics.
A close similarity between two things, or an attraction or sympathy for someone or something, especially because of shared characteristics.
Affinity maturation
The process by which activated B cells produce antibodies with increased affinity for antigen during the course of an immune response.
The process by which activated B cells produce antibodies with increased affinity for antigen during the course of an immune response.
AIDS
Acquired immune deficiency syndrome is a medical condition where the immune system cannot function properly and protect the body from disease. As a result, the body cannot defend itself against infections such as pneumonia. AIDS is caused by the Human Immunodeficiency Virus (HIV). This virus is spread through direct contact with the blood and body fluids of an infected individual. High risk activities include unprotected sexual intercourse and intravenous drug use (sharing needles). There is no cure for AIDS; however, research efforts to develop a vaccine are ongoing.
Acquired immune deficiency syndrome is a medical condition where the immune system cannot function properly and protect the body from disease. As a result, the body cannot defend itself against infections such as pneumonia. AIDS is caused by the Human Immunodeficiency Virus (HIV). This virus is spread through direct contact with the blood and body fluids of an infected individual. High risk activities include unprotected sexual intercourse and intravenous drug use (sharing needles). There is no cure for AIDS; however, research efforts to develop a vaccine are ongoing.
Air Handling Unit (AHU)
The mechanical devices required to achieve the objectives of HVAC (Heating, Ventilation, and Air Conditioning), including cooling, heating, dehumidification, humidification, air purification, and other related purposes.
The mechanical devices required to achieve the objectives of HVAC (Heating, Ventilation, and Air Conditioning), including cooling, heating, dehumidification, humidification, air purification, and other related purposes.
Air sampling
A process used to determine what airborne contaminants are present in an environment.
A process used to determine what airborne contaminants are present in an environment.
Airborne particle
Sub-micron particle invisible to the naked eye, which includes pathogens, dust, dirt, soot, smoke, and liquid droplets.
Sub-micron particle invisible to the naked eye, which includes pathogens, dust, dirt, soot, smoke, and liquid droplets.
Airlock
Compartment which permits passage between environments of differing atmospheric pressure or composition while minimizing the mixing of environments or change in pressure in the adjoining spaces.
Compartment which permits passage between environments of differing atmospheric pressure or composition while minimizing the mixing of environments or change in pressure in the adjoining spaces.
Airtight container
A container that prevents intrusion of foreign solids or liquids in normal handling or storage conditions and prevents loss, deterioration, degradation, or evaporation of the contents of pharmaceuticals.
A container that prevents intrusion of foreign solids or liquids in normal handling or storage conditions and prevents loss, deterioration, degradation, or evaporation of the contents of pharmaceuticals.
Allergy
Various conditions caused by hypersensitivity of the immune system to typically harmless substances in the environment. These diseases include hay fever, food allergies, atopic dermatitis, allergic asthma, and anaphylaxis. Symptoms may include red eyes, an itchy rash, sneezing, coughing, a runny nose, shortness of breath, or swelling.
Various conditions caused by hypersensitivity of the immune system to typically harmless substances in the environment. These diseases include hay fever, food allergies, atopic dermatitis, allergic asthma, and anaphylaxis. Symptoms may include red eyes, an itchy rash, sneezing, coughing, a runny nose, shortness of breath, or swelling.
Allocation concealment
Technique of ensuring that implementation of the random allocation sequence occurs without knowledge of which patient will receive which treatment or placebo.
Technique of ensuring that implementation of the random allocation sequence occurs without knowledge of which patient will receive which treatment or placebo.
Alternative Hypothesis
An opposing theory to the null hypothesis, which generally states that there is statistical significance between two variables.
An opposing theory to the null hypothesis, which generally states that there is statistical significance between two variables.
Amendment
Changes made to a clinical trial after it has received regulatory approval.
Changes made to a clinical trial after it has received regulatory approval.
Analyte
A chemical substance that is the subject of chemical analysis.
A chemical substance that is the subject of chemical analysis.
Anaphylaxis
An immediate and severe allergic reaction to a substance such as a food or drug. Symptoms of anaphylaxis include breathing difficulties, loss of consciousness, and a drop in blood pressure. This condition can be fatal and requires immediate medical attention.
An immediate and severe allergic reaction to a substance such as a food or drug. Symptoms of anaphylaxis include breathing difficulties, loss of consciousness, and a drop in blood pressure. This condition can be fatal and requires immediate medical attention.
Animal model
A living, non-human, often genetic-engineered animal used during the research and investigation of human disease, for the purpose of better understanding the disease process without the risk of harming a human.
A living, non-human, often genetic-engineered animal used during the research and investigation of human disease, for the purpose of better understanding the disease process without the risk of harming a human.
Antagonism
Inhibition of or interference with the action of one substance or organism by another.
Inhibition of or interference with the action of one substance or organism by another.
Anthrax
An acute infectious disease caused by the spore-forming bacterium Bacillus anthracis. Anthrax most commonly occurs in hoofed mammals but can infect humans.
An acute infectious disease caused by the spore-forming bacterium Bacillus anthracis. Anthrax most commonly occurs in hoofed mammals but can infect humans.
Antibody
A protein found in the blood, produced in response to foreign substances (e.g., bacteria or viruses) invading the body. Antibodies protect the body from disease by binding to invading organisms and destroying them.
A protein found in the blood, produced in response to foreign substances (e.g., bacteria or viruses) invading the body. Antibodies protect the body from disease by binding to invading organisms and destroying them.
Antigen
Foreign substances (e.g., bacteria or viruses) in the body that are capable of causing disease. The presence of antigens in the body triggers an immune response, usually the production of antibodies.
Foreign substances (e.g., bacteria or viruses) in the body that are capable of causing disease. The presence of antigens in the body triggers an immune response, usually the production of antibodies.
Antigen presenting cell
A type of immune cell that boosts immune responses by showing antigens on its surface to other cells of the immune system.
A type of immune cell that boosts immune responses by showing antigens on its surface to other cells of the immune system.
Antigenicity
The ability to specifically combine with the final products of the immune response.
The ability to specifically combine with the final products of the immune response.
Antimicrobial Consumption (AMC)
Estimates of aggregated data, often obtained from import, manufacturer, or reimbursement records.
Estimates of aggregated data, often obtained from import, manufacturer, or reimbursement records.
Antimicrobial Resistance (AMR)
The ability of microorganisms to persist or grow in the presence of drugs designed to inhibit or kill them.
The ability of microorganisms to persist or grow in the presence of drugs designed to inhibit or kill them.
Antisense RNA
Single-chain RNA binds to the target RNA in a sequence that is complementary to the RNA sequence at a certain site and inhibits its action.
Single-chain RNA binds to the target RNA in a sequence that is complementary to the RNA sequence at a certain site and inhibits its action.
Antiseptic
Substances used to slow or inhibit the growth of infectious microorganisms.
Substances used to slow or inhibit the growth of infectious microorganisms.
Antitoxin
A solution of antibodies against a toxin. Antitoxin can be derived from either human (e.g., tetanus immune globulin) or animal (usually equine) sources (e.g., diphtheria and botulism antitoxin). Antitoxins are used to confer passive immunity and for treatment.
A solution of antibodies against a toxin. Antitoxin can be derived from either human (e.g., tetanus immune globulin) or animal (usually equine) sources (e.g., diphtheria and botulism antitoxin). Antitoxins are used to confer passive immunity and for treatment.
Antiviral
A medicine capable of destroying or weakening a virus.
A medicine capable of destroying or weakening a virus.
Applicability
The possibility of generalizing and applying the results from a clinical trial.
The possibility of generalizing and applying the results from a clinical trial.
Applicable Regulatory Requirement
The applicable laws, applicable codes and guidelines and the requirements of any regulatory authority which are applicable in regard to clinical trial.
The applicable laws, applicable codes and guidelines and the requirements of any regulatory authority which are applicable in regard to clinical trial.