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

posted by yogeshla – India, 2021-01-05 07:01 (206 d 03:33 ago) – Posting: # 22173
Views: 947

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
21,592 posts in 4,514 threads, 1,532 registered users;
online 9 (0 registered, 9 guests [including 5 identified bots]).
Forum time: Friday 11:35 CEST (Europe/Vienna)

It is a capital mistake to theorise before one has data.    Arthur Conan Doyle

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