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RegisterTmax [Nonparametrics]
Dear EM,
Here is the detailed question is "Confirm if the differences between Tmax for the reference product, and test are statistically significant. If not, this should be made clear in any subsequent report to the RMS. The critical factor here is to convince the assessor that steady state concentrations are of most clinical relevance in a medicinal product for use in a chronic condition (weeks, months or years), rather than a small difference in time to Tmax (hours)" This is a Venlafaxine study 150mg Delayed realease
Here is the detailed question is "Confirm if the differences between Tmax for the reference product, and test are statistically significant. If not, this should be made clear in any subsequent report to the RMS. The critical factor here is to convince the assessor that steady state concentrations are of most clinical relevance in a medicinal product for use in a chronic condition (weeks, months or years), rather than a small difference in time to Tmax (hours)" This is a Venlafaxine study 150mg Delayed realease
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Best Regards
Joshi
Best Regards
Joshi
Complete thread:
- Tmax chidambarajoshi 2008-08-13 10:02
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Tmax ElMaestro 2008-08-13 10:25
- Tmaxchidambarajoshi 2008-08-13 10:49
- Tmax (EU) Helmut 2008-08-13 13:48
- Tmax (EU) chidambarajoshi 2008-08-14 06:30
- Tmax (WinNonlin) Helmut 2008-08-14 20:12
- Tmax (WinNonlin) chidambarajoshi 2008-08-25 09:47
- Tmax (WinNonlin) SDavis 2008-11-18 19:47
- Tmax (WinNonlin) Helmut 2008-11-18 20:15
- Tmax (Phoenix WinNonlin 6.0/6.1) Helmut 2009-06-12 18:55
- Tmax (WinNonlin) Helmut 2008-08-14 20:12
- Tmax (EU) chidambarajoshi 2008-08-14 06:30
- Tmax (EU) Helmut 2008-08-13 13:48
- Tmaxchidambarajoshi 2008-08-13 10:49
- Tmax ElMaestro 2008-08-13 10:25
Ing. Helmut Schütz