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

posted by Ohlbe – France, 2019-11-25 15:16 (310 d 10:46 ago) – Posting: # 20866
Views: 1,326

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.


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