Cmax ER = Cmax IR ? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-12-06 17:45  – Posting: # 20949
Views: 703

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.

Cheers,
Helmut Schütz
[image]

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

Complete thread:

Activity
 Admin contact
20,336 posts in 4,270 threads, 1,401 registered users;
online 17 (1 registered, 16 guests [including 8 identified bots]).
Forum time (Europe/Vienna): 11:36 CET

Medical statistician: One who will not accept that Columbus discovered America…
because he said he was looking for India in the trial plan.    Stephen Senn

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