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

posted by dshah – India/United Kingdom, 2021-02-17 07:35 (289 d 04:30 ago) – Posting: # 22212
Views: 804

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]

Complete thread:

Activity
 Admin contact
21,785 posts in 4,556 threads, 1,547 registered users;
online 10 (1 registered, 9 guests [including 5 identified bots]).
Forum time: Friday 12:05 CET (Europe/Vienna)

A drug is that substance which, when injected into a rat,
will produce a scientific report.    Anonymous

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5