FDA and EMA Regulatory Recommendations on Fed Bioequivalence Study in Healthy Subjects vs. Patients for Generic Drug Development

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Author/sBae, Jihyun; Tran, Tony; Nguyen, Duyen; Borges, Silvana; Kim, Myong-Jin.; Shon, Jihong; Li, Karen
Date:10/12/2024
Meeting Name:American College of Clinical Pharmacology (ACCP) 2024 Annual Meeting
State:AZ
City:Phoenix