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

posted by kratos – India, 2021-08-03 10:38 (296 d 08:50 ago) – Posting: # 22500
Views: 1,935

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
 Admin contact
22,105 posts in 4,630 threads, 1,566 registered users;
online 7 (0 registered, 7 guests [including 4 identified bots]).
Forum time: Thursday 19:29 CEST (Europe/Vienna)

Operational hectic replaces
intellectual calms.    Alexander Huiskes

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