Blind Review

Reviewing and evaluating study data during the period between the end of an intended analysis and the unblinding of the clinical trial.

Blinding/Masking

Steps taken to ensure that all persons involved in a trial are unaware of the type of treatment that each participant receives.

Booster effect

Effect after booster dose (extra administration of a vaccine after an earlier dose). Immunity against the antigen is increased back to protective levels after memory against that antigen has declined through time.

Buccal Tablet

A tablet placed between gum and inner lining of cheek for absorption.

Blending

To mix or combine things together.

Blood-Brain Barrier (BBB)

Blood-brain barrier. A gateway made up of endothelial cells that exist between blood and brain tissue. Unlike endothelial cells in other organs, the cells are very dense and therefore the drug does not permeate well.

Body Burden

The total amount of a particular chemical present in a human’s or animal’s body, typically a radioactive element or other toxic substance.

Bone marrow

Soft tissue located within bones that produces all blood cells, including the ones that fight infection.

Booster shots

Additional doses of a vaccine needed periodically to “boost” the immune system and ”reactivate” an immune response already developed by an individual. For example, a tetanus and diphtheria (Td) vaccine booster is recommended for adults every ten years.

Brachial neuritis

Inflammation of nerves in the arm causing muscle weakness and pain.

Buffer

A solution that resists changes in pH when acid or alkali is added to it. Buffers typically involve a weak acid or alkali together with one of its salts.

Bulk Product

Any product that has completed all processing stages up to, but not including, final packaging.

Bio-Derived Products

Wholly or partly derived from materials of biological origin, excluding materials embedded in geological formations and/or fossilized.

Biomedicine

Branch of medical science that applies biological and physiological principles to clinical practice.

Bioassay

Measurement of the concentration or potency of a substance by its effect on living cells or tissues.

Biopharmaceutical

Medicine and drugs produced using biotechnology involve the use of living things, especially cells and bacteria, in industrial processes.

Bioavailability

Fraction (%) of an administered drug that reaches the systemic circulation.

Biosafety

Safe working practices associated with handling of biological materials, particularly infectious agents.

Biobetter

New drugs designed from existing ones with improved properties such as higher selectivity, stability, half-life and/or lower toxicity/immunogenicity.

Biosafety Risk Group

Denotes the containment conditions required for safe handling of organisms associated with different hazards, ranging from Risk Group 1 (lowest risk, no or low individual and community risk, and unlikely to cause disease) to Risk Group 4 (highest risk, high individual and community risk, usually causes severe disease, and which is likely to spread with no prophylaxis or treatment available)

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.

Biosimilar (Subsequent Entry Biologics)

A biologic medical product that is almost an identical copy of an original product that is manufactured by a different company and was previously been licensed.

Bioequivalence (BE)

The biochemical similarity of two (or more) drugs that share the same active ingredient(s) and desired outcome(s) for patients.

Biostatistics

Statistics applied to the collection, analysis, and interpretation of biological data and especially data relating to human biology, health, and medicine.

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.

Biohazard

Any biological material considered to be hazardous to people and/or the environment.

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.

Biological Agents

Microorganisms, including genetically engineered microbes, cell culture media, and endoparasites, regardless of their pathogenicity.

Barometer

A device used to measure atmospheric pressure.

Biological patent

A type of intellectual property protection granted for inventions related to biological or biotechnological processes, materials, or products.

Baseline Imbalance

The difference between the control group and the experimental group at the baseline, where no intervention has been applied.

Biological plausibility

A causal association (or relationship between two factors) consistent with existing medical knowledge.

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.

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).

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.

Biologics

A class of therapeutics that are produced using biological processes involving recombinant DNA technology.

Batch Record

The documented execution detail of the manufacturing process of a regulated product, including authors, steps, materials, and equipment.

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.

Bias

Flaws or undesired effects in the collection, analysis, or interpretation of research data that lead to incorrect or inaccurate conclusions.

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.

Binary Data

Data whose unit can take on only two possible states.

Biomass probe

Probes used for monitoring of cell viability and count in culture.