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

posted by jag009  – NJ, 2020-05-11 06:29 (87 d 08:50 ago) – Posting: # 21417
Views: 1,310

» 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 :))


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