Comparative PK [Study Per­for­mance]

posted by PVRC – India, 2021-05-10 18:12 (139 d 12:22 ago) – Posting: # 22338
Views: 877

Hi all,

For one of the product, the agency recommend to demonstrate comparative PK in the absence of bioequivalence. The question is that whether all bioequivalence criteria (like 80-125%, group effect etc.,) are still applicable to demonstrate comparative PK.

Thanks in advance....

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