Comparative PK? [Study Per­for­mance]

posted by PVRC – India, 2021-05-20 09:41 (564 d 07:34 ago) – Posting: # 22361
Views: 1,130

❝ can you give us the context? Which guidance are you referring to (a link would be nice)? Did you really fail to show BE?


Hi Helmut,

the description given is not from the guidance but from the responses from FDA to one of the questions in the pIND meeting. FDA recommended to demonstrate comparable PK in case bioequivalence is not established for different reasons in the fasted and fed state.


Thanks with best regards

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