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Nataliia ☆ Ukraine, 2021-02-16 14:08 (1156 d 20:05 ago) Posting: # 22211 Views: 1,659 |
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Dear colleagues, does anyone have the experience in conducting in vitro study with the nasogastric tube? According to FDA Draft Guidance: «The T/R recovery ratio and the 90% confidence interval of the T/R recovery ratio should be calculated», but bioequivalence CI limits were not specified. Would you kindly write CI limits for in vitro study with the nasogastric tube? Is it 80,00-125,00? |
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dshah ★★ India/United Kingdom, 2021-02-17 08:35 (1156 d 01:38 ago) @ Nataliia Posting: # 22212 Views: 1,375 |
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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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Nataliia ☆ Ukraine, 2021-03-01 16:37 (1143 d 17:36 ago) @ dshah Posting: # 22237 Views: 1,211 |
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Dear Dshah, I am grateful for this extremely useful infofmation on in vitro feeding tube testing Kind regards, Nataliia Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut] |
Ing. Helmut Schütz