necessity of retention samples for pilot BE study [Regulatives / Guidelines]

posted by Shuanghe  – Spain, 2019-11-25 18:00 (254 d 19:54 ago) – Posting: # 20868
Views: 1,121

Dear Ohlbe,

» As pilot trials are not "required for approval", I would understand that retention samples are not needed for pilot studies. But I'm not a specialist of FDA regulations and John may have a different interpretation.

Thanks! That's certainly one standpoint to look at the regulatory requirement, and it make sense to me. I guess that I missed this point when I read the CFR. Let's see what else we can have in this forum.

All the best,
Shuanghe

Complete thread:

Activity
 Admin contact
20,969 posts in 4,374 threads, 1,460 registered users;
online 24 (1 registered, 23 guests [including 11 identified bots]).
Forum time: Thursday 14:54 CEST (Europe/Vienna)

It is a good morning exercise for a research scientist
to discard a pet hypothesis every day before breakfast.
It keeps him young.    Konrad Lorenz

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5