Cmax ER = Cmax IR ? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-12-06 16:41 (654 d 22:27 ago) – Posting: # 20945
Views: 2,188

Hi John,

» […] a study comparing ER once a day vs IR given multi-times a days, e.g, ER vs IR given every 4 hours. When conducting such studies, the success criteria is based on equivalent AUC (90% CI), and not Cmax due to the nature of the ER drug release kinetic.
»
» I received a comment from the mexico regulatory when they reviewed the protocol. They wanted Cmax as an equivalent criteria as well …

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

Dif-tor heh smusma 🖖
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
21,691 posts in 4,534 threads, 1,541 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Tuesday 16:09 CEST (Europe/Vienna)

“Data! Data! Data!” he cried impatiently.
“I can’t make bricks without clay!”    Arthur Conan Doyle

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