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

posted by dshah – India/ United Kingdom, 2021-01-05 08:06 (255 d 09:20 ago) – Posting: # 22174
Views: 895

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
21,687 posts in 4,534 threads, 1,542 registered users;
online 8 (1 registered, 7 guests [including 5 identified bots]).
Forum time: Friday 18:26 CEST (Europe/Vienna)

Genius is that which forces
the inertia of humanity to learn.    Henri Bergson

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