Cmax ER = Cmax IR ? [Regulatives / Guidelines]

posted by jag009  – NJ, 2019-12-06 21:21 (452 d 03:29 ago) – Posting: # 20950
Views: 1,922

Hi Helmut (and guys and girls)

» Had that on this side of the pond as well (called a “hybrid application”); multiphasic product. Cmax was doable but only with expanded limits.

Do you know of any articles which say that Cmax is not a primary parameter (for equivalence) for ER product, when compared to IR?

Thx
john

Complete thread:

Activity
 Admin contact
21,359 posts in 4,460 threads, 1,492 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: Wednesday 00:50 CET (Europe/Vienna)

The art and science of asking questions
is the source of all knowledge.    Thomas Berger

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