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Bioequivalence Studies with Pharmacokinetic Endpoints for ...

Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA Lei Zhang, Ph.D. Deputy Director Office of Research and Standards Office of Generic Drugs CDER, U.S. FDA February 24, 2022 SBIA Webinar Nilufer Tampal, Ph.D. Associate Director of Scientific Quality Office of Bioequivalence Office of Generic Drugs CDER, U.S. FDA

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