Scaling/Widening of AUC [Regulatives / Guidelines]

posted by Loky do – Egypt, 2021-02-24 13:13 (78 d 05:52 ago) – Posting: # 22227
Views: 913

Also Regarding AUC widening, is it applicable in both partially and fully replicate designs or fully replicate design only as FDA referred to the published book chapter for RSABE for AUC and Cmax in fda draft guidance for progesterone? So could we apply it in general or it’s not applicable?

Complete thread:

 Admin contact
21,460 posts in 4,486 threads, 1,511 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Thursday 20:06 CEST (Europe/Vienna)

Nothing in the world is more dangerous
than sincere ignorance
and conscientious stupidity.    Martin Luther King, Jr.

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