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

posted by Shuanghe  – Spain, 2019-11-25 17:00 (330 d 05:50 ago) – Posting: # 20868
Views: 1,339

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
21,170 posts in 4,411 threads, 1,474 registered users;
online 9 (0 registered, 9 guests [including 4 identified bots]).
Forum time: Tuesday 22:50 UTC (Europe/Vienna)

But it is in matters beyond the limits of mere rule
that the skill of the analyst is evinced.
He makes in silence a host of observations and inferences…    Edgar Allan Poe

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