Terminology
Definition
Description
Arthritis
A medical condition characterized by inflammation of the joints, which causes pain and difficulty moving.
Asepsis
A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbial contamination of the exposed sterile product
Aseptic
Medically clean or without infection.
Aseptic Process Simulation (APS)
A simulation of the entire aseptic manufacturing process in order to verify the capability of the process to ensure product sterility. APS includes all aseptic operations associated with routine manufacturing (for example, equipment assembly, formulation, filling, lyophilization and sealing processes, as necessary).
Aseptic Processing
Handling sterile materials in a controlled environment, in which the air supply, materials, equipment, and personnel are regulated to control microbial and particulate contamination to acceptable levels.
Assay
A laboratory test to find and measure the presence and the amount of a particular sample(blood, urine, or any biological material).
Association
The degree to which the occurrence of two variables or events is linked. Association describes a situation where the likelihood of one event occurring is related to the presence of another event or variable. However, an association between two variables does not necessarily imply a cause-and-effect relationship. The term association and relationship are often used interchangeably.
Asthma
A long-term inflammatory disease of the airways of the lungs caused by exposure to air pollution and allergens. It is characterized by variable and recurring symptoms, reversible airflow obstruction. Symptoms include episodes of wheezing, coughing, chest tightness, and shortness of breath.
Asymptomatic infection
The presence of infection without symptoms. Also known as inapparent or subclinical infection.
Attenuated vaccine
A vaccine in which a live virus is weakened (attenuated) through chemical or physical processes in order to produce an immune response without the severe effects of the disease. Attenuated vaccines currently licensed in the United States include measles, mumps, rubella, varicella, rotavirus, yellow fever, smallpox, and some formulations of influenza and typhoid vaccines.
Attrition Bias
A type of selection bias due to systematic differences between study groups in the number and the way participants are lost from a study.
Audit
A systematic and independent investigation conducted by the sponsor or others to ensure that the clinical trial is conducted in accordance with the protocol, the sponsor’s standard operating procedures, good clinical practice, and applicable regulatory requirements, in order to ensure the reliability of the data collected in the clinical trial.
Authentication
An act, process, or method of showing something to be real, true, or genuine.
Autism spectrum disorder (ASD)
A developmental disability that can cause significant social, communication, and behavioral challenges. ASD is usually diagnosed between 18 and 30 months of age. At this time, the cause of autism is not known although many experts believe it to be a genetically based disorder that occurs before birth.
Autoimmunity
The immune system defends the body against infections and certain other diseases.
Automated System
Any computers, software, firmware, HVAC systems, elevators, electrical systems, fire or life safety systems, security systems and any other electrical, mechanized or computerized devices serving the Project.
Auxiliary
A helper; an assistant.
Auxiliary medical products (AMP)
A medicinal product used for the needs of a clinical trial as described in the protocol, but not as an investigational medicinal product.
Average Atomic Weight
The weighted average mass of the atoms in a naturally occurring sample of the element.
B cells
Small white blood cells that help the body defend itself against infection. B cells are produced in bone marrow and can develop into plasma cells which produce antibodies. Also known as B lymphocytes.
Bacteria
Tiny one-celled organisms present throughout the environment that require a microscope to be seen. While not all bacteria are harmful, some cause disease. Examples of bacterial disease include diphtheria, pertussis, tetanus, respiratory tract infections caused by Haemophilus influenzae and pneumococcus.
Bacterial polysaccharides
Bacterial polysaccharides exist in the form of lipopolysaccharide, peptidoglycan, or in the form of a capsule. Polysaccharides are part of bacterial cell wall acting as a skeleton while they can also impart virulence to the bacterial system, such as poly-N-acetyl-glucosamine in bacterium Staphylococcus aureus.
Barometer
A device used to measure atmospheric pressure.
Baseline Imbalance
The difference between the control group and the experimental group at the baseline, where no intervention has been applied.
Basophil
A type of white blood cell, representing about 0.5% to 1% of circulating white blood cells. It produces compounds that coordinate immune responses, including histamine and serotonin and is responsible for inflammatory reactions during immune response, as well as in the formation of acute and chronic allergic diseases.
Batch / Lot
A defined quantity of starting material, packaging material, or product processed in a single process or series of processes so that it is expected to be homogeneous.
Batch Record
The documented execution detail of the manufacturing process of a regulated product, including authors, steps, materials, and equipment.
Bharat Biotech International Limited (BBIL)
Indian multinational biotechnology company engaged in drug discovery, drug development, and the manufacture of vaccines, biotherapeutics, pharmaceuticals and healthcare products.
Bias
Flaws or undesired effects in the collection, analysis, or interpretation of research data that lead to incorrect or inaccurate conclusions.
Bill & Melinda Gates Foundation (BMGF)
A private philanthropic foundation founded by Bill Gates and Melinda Gates.
Binary Data
Data whose unit can take on only two possible states.
Bio-Derived Products
Wholly or partly derived from materials of biological origin, excluding materials embedded in geological formations and/or fossilized.
Bioassay
Measurement of the concentration or potency of a substance by its effect on living cells or tissues.
Bioavailability
Fraction (%) of an administered drug that reaches the systemic circulation.
Biobetter
New drugs designed from existing ones with improved properties such as higher selectivity, stability, half-life and/or lower toxicity/immunogenicity.
Bioburden
The total number of microorganisms associated with a specific item, such as personnel, manufacturing environments (air and surfaces), equipment, product packaging, raw materials (including water), in-process materials or finished products.
Bioequivalence (BE)
The biochemical similarity of two (or more) drugs that share the same active ingredient(s) and desired outcome(s) for patients.
Biohazard
Any biological material considered to be hazardous to people and/or the environment.
Biological Agents
Microorganisms, including genetically engineered microbes, cell culture media, and endoparasites, regardless of their pathogenicity.
Biological patent
A type of intellectual property protection granted for inventions related to biological or biotechnological processes, materials, or products.
Biological plausibility
A causal association (or relationship between two factors) consistent with existing medical knowledge.
Biological Starting Material
Starting materials derived from a biological source that mark the beginning of the manufacturing process of a drug, as described in a marketing authorization or licence application, and from which the active ingredient is derived either directly (for example, plasma derivatives, ascitic fluid and bovine lung) or indirectly (for example, cell substrates, host/vector production cells, eggs and viral strains).
Biologics
A class of therapeutics that are produced using biological processes involving recombinant DNA technology.
Biologics License Application (BLA)
A request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce in the United States
Biomanufacturing
The use of living organisms, particularly microorganisms and cells to produce molecules or other biological materials for making products such as medicines, food, and drinks.
Biomarker
A biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease.
Biomass probe
Probes used for monitoring of cell viability and count in culture.
Biomedicine
Branch of medical science that applies biological and physiological principles to clinical practice.
Biopharmaceutical
Medicine and drugs produced using biotechnology involve the use of living things, especially cells and bacteria, in industrial processes.
Biosafety
Safe working practices associated with handling of biological materials, particularly infectious agents.