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USFDA Guidance: Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA & Statistical Approaches to Establishing Bioequivalence
Bioequivalence (BE) plays a critical role in generic drug development by demonstrating that a generic product performs similarly to its reference listed drug (RLD). To support approval of an Abbreviated New Drug Application (ANDA), manufacturers must establish that the proposed generic product delivers a comparable rate and extent of drug absorption under similar conditions of use. The FDA’s updated guidances, Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Su
Sharan Murugan
May 313 min read