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Impurities
Impurities refer to unwanted substances or contaminants present in API or drug product. It can arise during manufacturing, handling, or ...
Innovator Drug
Innovator drug is a first time developed drug product through extensive research and clinical trials to demonstrate safety and efficacy. ...
Misbranded
A misbranded drug is a pharmaceutical product that has misleading information or false labeling or illegal advertising and violating regulatory ...
Over-the-Counter (OTC) Drug
OTC drugs are medications that can be purchased without a prescription for the treatment of minor ailments and conditions. As ...
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 ...