Consideration Factors for Study Population Selection in Bioequivalence Studies with Pharmacokinetic Endpoints

Back to: Facilitating Generic Drug Product Development through Product-Specific Guidances

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Presenter

Jihong Shon, MD, PhD
Senior Staff Fellow
Division of Therapeutic Performance II (DTP II)
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)