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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 ...
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 ...
Orange Book
The Orange Book contains Approved Drug Products With Therapeutic Equivalence Evaluations, identifies drug products approved on the basis of safety ...
Drug Discovery
Drug discovery is the process by which new candidate medications are discovered and involves a comprehensive scientific and research-based approach ...
Generic Drug
Generic drugs are similar to brand-name drugs (RLD/RS). They have the same active ingredients and similar efficacy. The regulatory body ...