No acceptance criteria widening for AUC in Europe [Regulatives / Guidelines]

posted by vixen – Czechia, 2021-07-30 20:44 (993 d 13:50 ago) – Posting: # 22488
Views: 1,984

Hi Prasad,

Can't comment on the WHO or HKG, but in Europe you would be only allowed to widen the acceptance criteria for Cmax (not for AUC) and under the conditions that:Cheers,
vixen

Complete thread:

UA Flag
Activity
 Admin contact
22,987 posts in 4,824 threads, 1,663 registered users;
91 visitors (0 registered, 91 guests [including 5 identified bots]).
Forum time: 10:34 CEST (Europe/Vienna)

The only way to comprehend what mathematicians mean by Infinity
is to contemplate the extent of human stupidity.    Voltaire

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