Comparative PK? [Study Per­for­mance]

posted by PVRC – India, 2021-05-20 07:41 (252 d 03:24 ago) – Posting: # 22361
Views: 770

» 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

Complete thread:

 Admin contact
21,854 posts in 4,573 threads, 1,554 registered users;
online 18 (0 registered, 18 guests [including 17 identified bots]).
Forum time: Thursday 10:05 CET (Europe/Vienna)

Try to learn something about everything
and everything about something.    Thomas Henry Huxley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz