ICH Terms
Biodistribution (BD)
BD is the in vivo distribution, persistence, and clearance of a gene therapy (GT) product at the site of administration ...
Bioburden
The level and type (e.g. objectionable or not) of micro-organisms that can be present in raw materials, Active Pharmaceutical Ingredient ...
Biological Activity, Drugs and Matrix
Biological Activity The specific ability or capacity of the product to achieve a defined biological effect. Potency is the quantitative ...
Business Case
The reason for making an investment (in whatever form), performing a process or using a tool. It often includes economic ...
Batch and Batch Number
Batch A defined quantity of starting material, packaging material or finished pharmaceutical product processed in a single process or series ...
Bracketing
The design of a stability schedule such that only samples on the extremes of certain design factors, e.g., strength, package ...
Adverse Drug Reaction (ADR)
E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting — Step 4 (final); 27 October 1994 — II.A.2 ...
Acceptance Criteria
Q6A Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances — Step ...
Accelerated Testing
Q1A(R2) Stability Testing of New Drug Substances and Products — Step 4 (final); 6 February 2003 –Glossary Studies designed to ...