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RegisterBE 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 :))
J
Complete thread:
- BE XR OD vs IR BID - which Cmax for IR? Nathalie T 2020-05-08 16:40 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDA ER vs. IR: Global Cmax Helmut 2020-05-09 11:54
- FDA ER vs. IR: Global Cmax for Day 1 too? Nathalie T 2020-05-11 15:59
- Global Cmax (MD and SD) Helmut 2020-05-11 17:51
- FDA ER vs. IR: Global Cmax for Day 1 too? Nathalie T 2020-05-11 15:59
- BE XR OD vs IR BID - which Cmax for IR?jag009 2020-05-11 06:29
- BE XR OD vs IR BID - which Cmax for IR on day 1? Nathalie T 2020-05-11 16:02
- BE XR OD vs IR BID - which Cmax for IR on day 1? jag009 2020-05-12 21:16
- BE XR OD vs IR BID - which Cmax for IR on day 1? Nathalie T 2020-05-18 16:23
- BE XR OD vs IR BID - which Cmax for IR on day 1? jag009 2020-05-12 21:16
- BE XR OD vs IR BID - which Cmax for IR on day 1? Nathalie T 2020-05-11 16:02
- FDA ER vs. IR: Global Cmax Helmut 2020-05-09 11:54
Ing. Helmut Schütz