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

posted by Ohlbe – France, 2019-11-25 14:16 (510 d 06:35 ago) – Posting: # 20866
Views: 1,547

Dear Shuanghe,

» I'm surprised that among so many questions with regard to retention samples that have been asked in the forum, I couldn't find the answer that I'm looking for. My question is not related to the quantity, but to the necessity for pilot BE.

If I read 21CFR320.63 correctly, it says:

The applicant of an abbreviated application or a supplemental application submitted under section 505 of the Federal Food, Drug, and Cosmetic Act, or, if bioequivalence testing was performed under contract, the contract research organization shall retain reserve samples of any test article and reference standard used in conducting an in vivo or in vitro bioequivalence study required for approval of the abbreviated application or supplemental application.

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.

Regards
Ohlbe

Complete thread:

Activity
 Admin contact
21,419 posts in 4,475 threads, 1,508 registered users;
online 18 (0 registered, 18 guests [including 4 identified bots]).
Forum time: Sunday 20:52 UTC (Europe/Vienna)

Nothing fails like success because you do not learn anything from it.
The only thing we ever learn from is failure.
Success only confirms our superstitions.    Kenneth E. Boulding

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