95% upper bound limit as per FDA for fully replicate crossover BE study [RSABE / ABEL]

posted by dshah – India, 2021-01-05 08:06 (10 d 22:47 ago) – Posting: # 22174
Views: 176

Hi Yogeshla!

» Suppose 95% UB result is 0.001, is it acceptable to FDA?

The 95% UB would not be acceptable for 0.001.

Regards,
dshah

Complete thread:

Activity
 Admin contact
21,303 posts in 4,441 threads, 1,488 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time: Saturday 06:53 CET (Europe/Vienna)

If you can’t solve a problem, then there is an easier problem
you can solve: find it.    George Pólya

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