Bioequivalence and Bioavailability Forum • necessity of retention samples for pilot BE study

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

posted by Shuanghe – Spain, 2019-11-25 19:00 (2407 d 13:45 ago) – Posting: # 20868
Views: 6,308

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:

necessity of retention samples for pilot BE study Shuanghe 2019-11-25 13:05
- necessity of retention samples for pilot BE study Ohlbe 2019-11-25 15:16
  - necessity of retention samples for pilot BE studyShuanghe 2019-11-25 18:00
- necessity of retention samples for pilot BE study ElMaestro 2019-11-25 17:38
  - necessity of retention samples for pilot BE study Shuanghe 2019-11-25 18:42
  - necessity of retention samples for pilot BE study nobody 2019-11-26 10:11