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

posted by jag009  – NJ, 2020-05-11 04:29 (162 d 18:50 ago) – Posting: # 21417
Views: 1,673

» 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:

Activity
 Admin contact
21,170 posts in 4,411 threads, 1,474 registered users;
online 4 (0 registered, 4 guests [including 2 identified bots]).
Forum time: Tuesday 23:19 UTC (Europe/Vienna)

But it is in matters beyond the limits of mere rule
that the skill of the analyst is evinced.
He makes in silence a host of observations and inferences…    Edgar Allan Poe

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