Скачать или смотреть Bioanalysis of Endogenous Compounds in PK BE Studies in ANDAs - Bioanalysis 2020

Zhen Zhang, CDER Office of Generic Drugs, explains how to identify challenges in establishing bioequivalence (BE) of drug products containing endogenous compounds. He also explains the regulatory requirements and approaches for bioanalysis and establishing BE of drug products containing endogenous compounds and shares two case studies.

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