BE XR OD vs IR BID - which Cmax for IR? [Regulatives / Guidelines]
❝ 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 Drugs@FDA.
Similar approach (Don't ask how I know :))
- BE XR OD vs IR BID - which Cmax for IR? Nathalie T 2020-05-08 16:40 [Regulatives / Guidelines]
- FDA ER vs. IR: Global Cmax Helmut 2020-05-09 11:54
- BE XR OD vs IR BID - which Cmax for IR?jag009 2020-05-11 06:29