in vitro study with the nasogastric tube, CI [Regulatives / Guidelines]

posted by dshah – India, 2021-02-17 07:35 (13 d 17:22 ago) – Posting: # 22212
Views: 174

Dear Nataliia!
Please find the link for summary tables for in vitro feeding tube testing by FDA. (
Also find the testing discussion by FDA in workshop - Advancing Innovative Science in Generic Drug Development Workshop
September 29 & 30, 2020 at Kindly see the presentation titled D2S16- tyner and D2S17-Kapoor. They are focusing on %Recovery and I am not able to find weather 90%CI criteria will be applicable or not.
Hope it helps you.
Dear Forum member - apologies for not giving link for topic but I am posting trough mobile device and not able to perform few features.

Edit: Link added. [Helmut]

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