Cmax ER = Cmax IR ? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-12-06 18:45 (1574 d 18:10 ago) – Posting: # 20949
Views: 2,679

Hi John,

❝ ❝ If you would succeed in demonstrating BE of Cmax you would have proven that your product is not an ER. Bizarre idea.


❝ Exactly. I am at a lost. I am not sure if the reviewer misread the protocol …


Might well be.

❝ … or he doesn't understand the concept.


Well,…

❝ Having said that (dont laugh), FDA once asked us to show BE for a 505b2 for an once day ER vs IR @ 4 hrs with respect to Cmax and AUC. It was v strange unless they are suspecting that Cmax is associated with efficacy (somehow).


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

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
102 visitors (0 registered, 102 guests [including 4 identified bots]).
Forum time: 12:55 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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