Confidence interval between two study for same test and reference lot [Study As­sess­ment]

posted by RahulG628 – India, 2021-08-04 17:40 (50 d 18:12 ago) – Posting: # 22506
Views: 1,316

Dear Helmut,

Thank you for allowing me to join forum.

Need your opinion on following point.

We conducted two BE study for one of the ANDA, in one study we got 90% CI (77-108) and another study we got (106-125.8) for same test and RLD lot. Will it possible to combine both study two justify product is bio-equivalent based on observe variability for regulatory submissions.

Thanks & Regards,
Rahul

Complete thread:

Activity
 Admin contact
21,694 posts in 4,535 threads, 1,541 registered users;
online 16 (1 registered, 15 guests [including 6 identified bots]).
Forum time: Friday 11:53 CEST (Europe/Vienna)

Tortured data will confess to anything.    Fredric Menger

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