WHO: scaling for AUC confirmed [BE/BA News]

posted by kratos – India, 2021-08-03 12:38 (938 d 21:54 ago) – Posting: # 22500
Views: 2,877

Hello everyone,
Just wanted to understand if the EMA would also start accepting scaling for AUC;
There are several locally acting products where the AUC could be more variable than the Cmax parameter.
At the moment it appears only the EMA has restricted scaling to Cmax parameter while other agencies have extended it to AUC as well.
Please, your thoughts on the same.

Complete thread:

UA Flag
Activity
 Admin contact
22,912 posts in 4,806 threads, 1,636 registered users;
31 visitors (0 registered, 31 guests [including 5 identified bots]).
Forum time: 09:32 CET (Europe/Vienna)

Exploratory analysis: The art of finding a Rembrandt
in a Jackson Pollock.    Stephen Senn

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