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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 ...
Blinding in Clinical Trials
A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually ...
Bridging Study
A bridging study is defined as a supplemental study performed in the new region to provide pharmacodynamic or clinical data ...
Business Case
The reason for making an investment (in whatever form), performing a process or using a tool. It often includes economic ...
Blending in Pharmaceutical Manufacturing
Blending is defined as the process of combining materials within the same specification to produce a homogeneous intermediate or API. ...
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 ...
GxP Topics
GxP refers to the guidelines for Good Practice in pharmaceutical industry for ensuring safety and efficacy of products. GxP compliance ...