Case Studies: Inadequate Bioequivalence Studies (18of28) Generic Drugs Forum – Apr. 3-4, 2019

Ke Ren from CDER Office of Generic Drugs’ Office of Bioequivalence III discusses inadequate studies from a regulatory perspective. She provides an overview of the regulatory criteria for in vivo bioequivalence (BE) studies, common BE deficiencies in pharmacokinetic (PK) studies, case studies on study design. She talks about how sampling time can be insufficient, washing out period insufficient to include the Tlag difference and scaling BE point estimate.

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