Chief Pharmacist
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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 ...
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Bioburden
The level and type (e.g. objectionable or not) of micro-organisms that can be present in raw materials, Active Pharmaceutical Ingredient ...
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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 ...
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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 ...
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Bridging Study
A bridging study is defined as a supplemental study performed in the new region to provide pharmacodynamic or clinical data ...
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Business Case
The reason for making an investment (in whatever form), performing a process or using a tool. It often includes economic ...
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Blending in Pharmaceutical Manufacturing
Blending is defined as the process of combining materials within the same specification to produce a homogeneous intermediate or API. ...
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Batch and Batch Number
Batch A defined quantity of starting material, packaging material or finished pharmaceutical product processed in a single process or series ...
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Bracketing
The design of a stability schedule such that only samples on the extremes of certain design factors, e.g., strength, package ...
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GxP Topics
GxP refers to the guidelines for Good Practice in pharmaceutical industry for ensuring safety and efficacy of products. GxP compliance ...