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Dear Helmut and John,
Even with prolonged release formulations giving a pseudo-plateau, slightly decreasing for T (tmax 6 hours), slightly increasing for R (tmax 12 hours) ? There you could get similar Cmax and AUC, with a different tmax, couldn't you ?
To come back to John's initial question:
If you have a situation like above, it should be possible to argue.
Regards
Ohlbe
❝ From a PK point of view I can’t imagine a situation where AUCt, AUC∞, and Cmax are equivalent and tmax is not (i.e, a large difference like in your OP).
Even with prolonged release formulations giving a pseudo-plateau, slightly decreasing for T (tmax 6 hours), slightly increasing for R (tmax 12 hours) ? There you could get similar Cmax and AUC, with a different tmax, couldn't you ?
To come back to John's initial question:
❝ Any roadblocks from regulatory agency (US, Europe, etc.)
If you have a situation like above, it should be possible to argue.
Regards
Ohlbe
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Tmax differences in BE studies jag009 2012-10-15 16:23
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Delayed release? Helmut 2012-10-15 16:41
- Delayed release? jag009 2012-10-15 19:38
- Delayed release? Helmut 2012-10-15 16:41
Ing. Helmut Schütz