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

posted by dshah – India, 2021-02-17 07:35 (83 d 01:33 ago) – Posting: # 22212
Views: 471

Dear Nataliia!
Please find the link for summary tables for in vitro feeding tube testing by FDA. (https://www.fda.gov/media/98853/download)
Also find the testing discussion by FDA in workshop - Advancing Innovative Science in Generic Drug Development Workshop
September 29 & 30, 2020 at https://sbiaevents.com/innov2020/. 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.
Regards,
Dshah


Edit: Link added. [Helmut]

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