Scaling/Widening of AUC [Regulatives / Guidelines]

posted by Loky do – Egypt, 2021-02-24 13:13 (535 d 11:53 ago) – Posting: # 22227
Views: 2,008

Dears
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designs or fully replicate design only as FDA referred to the published book chapter for RSABE for AUC and Cmax in fda draft guidance for progesterone?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:

UA Flag
Activity
 Admin contact
22,301 posts in 4,667 threads, 1,585 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: Sunday 02:07 CEST (Europe/Vienna)

No written law has ever been more binding than
unwritten custom supported by popular opinion.    Carrie Chapman Catt

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