BE XR OD vs IR BID - which Cmax for IR? [Regulatives / Guidelines]

posted by jag009  – NJ, 2020-05-11 08:29 (938 d 08:41 ago) – Posting: # 21417
Views: 3,079

❝ I would like to have the help of the forum participants on a tricky question, ie which IR Cmax should be considered to assess the potential bioequivalence between an IR formulation administered BID and an XR formulation administered OD on day 1 and at steady-state. This is for a submission to FDA.


Not sure if the following will answer your Q exactly and whether it still exists on FDA website (or they blacked out the results):
Look for Ultram ER at [email protected]
Similar approach (Don't ask how I know :))

J

Complete thread:

UA Flag
Activity
 Admin contact
22,428 posts in 4,694 threads, 1,598 registered users;
25 visitors (0 registered, 25 guests [including 11 identified bots]).
Forum time: 16:11 CET (Europe/Vienna)

Statistics is the art of never having to say you’re wrong.
Variance is what any two statisticians are at.    C.J. Bradfield

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