Cmax ER = Cmax IR ? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-12-06 16:41 (898 d 03:45 ago) – Posting: # 20945
Views: 2,269

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 🖖 [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
22,091 posts in 4,630 threads, 1,566 registered users;
online 15 (0 registered, 15 guests [including 14 identified bots]).
Forum time: Sunday 21:27 CEST (Europe/Vienna)

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

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