Scaling/Widening of AUC [Regulatives / Guidelines]

posted by Loky do – Egypt, 2021-02-24 13:13 (281 d 22:53 ago) – Posting: # 22227
Views: 1,572

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designs or fully replicate design only as FDA referred to the published book chapter for RSABE for AUC and Cmax in fda draft guidance for progesterone?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

Activity
 Admin contact
21,785 posts in 4,556 threads, 1,547 registered users;
online 9 (1 registered, 8 guests [including 4 identified bots]).
Forum time: Friday 12:07 CET (Europe/Vienna)

A drug is that substance which, when injected into a rat,
will produce a scientific report.    Anonymous

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