Chapter 12
Experience of Generic Drug Products with Multiple Components
12.1 Introduction
When an innovative drug product is going off patent protection, as indicated in Chapter 10, pharmaceutical or generic companies may file an Abbreviated New Drug Application (ANDA) for generic approval. As indicated in 21 CFR 320.24, bioavailability and bioequivalence may be established by in vivo and in vitro studies or with suitable justification by in vitro studies alone. In vivo studies include pharmacokinetic/pharmacodynamic (PK/PD) studies, bioavailability/bioequivalence (BA/BE) studies, and clinical studies, while in vitro studies are referred to as dissolution test/dissolution profile comparison and in vitro tests for content uniformity, prime/re-prime, ...
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