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

posted by yogeshla – India, 2021-01-05 07:01 (10 d 22:59 ago) – Posting: # 22173
Views: 205

Hi All,

Can anyone confirm, till what decimal is acceptable for 95% upper bound limit as per FDA criteria?
Suppose 95% UB result is 0.001, is it acceptable to FDA?

Criteria is less than or equal to zero.


Edit: Category changed; see also this post #1[Helmut]

Complete thread:

Activity
 Admin contact
21,303 posts in 4,441 threads, 1,488 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Saturday 06:00 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