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

posted by Shuanghe  – Spain, 2019-11-25 13:05  – Posting: # 20865
Views: 505

Dear All,

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.

According to FDA's guidance (21CRF), sufficient retention samples (5 times complete analysis or 300 units etc ) should be kept in CRO where the BE studies were conducted. The guidance doesn't mention if this is for pilot or pivotal. Obviously, you need this for pivotal BE, but what about pilot BE?

Our practice (SOP) is to send sufficient retention samples for any BE, regardless of pilot or pivotal. However, recently, we had a problem with one Indian CRO. I was told by them that DCGI might problem with this large than necessary amount of product for pilot BE. We cited the FDA's guidance but they still refuse it.

So this is the background of my asking here. What are your opinions and experiences? Should it be sent for pilot BE? Thanks.

All the best,
Shuanghe

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