Nataliia
☆    

Ukraine,
2021-02-16 13:08
(16 d 10:00 ago)

Posting: # 22211
Views: 254
 

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

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According to FDA Draft Guidance: «The T/R recovery ratio and the 90% confidence interval of the T/R recovery ratio should be calculated», but bioequivalence CI limits were not specified.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?
dshah
☆    

India,
2021-02-17 07:35
(15 d 15:33 ago)

@ Nataliia
Posting: # 22212
Views: 201
 

 in vitro study with the nasogastric tube, CI

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]
Nataliia
☆    

Ukraine,
2021-03-01 15:37
(3 d 07:31 ago)

@ dshah
Posting: # 22237
Views: 73
 

 in vitro study with the nasogastric tube, CI

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]
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