Log in
RegisterMPH examples [BE/BA News]
Dear Helmut!
Thanx for that answer. Elaborate and concise as always.
Excerpt from my next report: "We have evaluated the partial Cmax according to Schütz ..." 
In the extremal case this would mean that the Cmax values are the same in both phases! See the red curve of your example picture.
Me too.
Your cut-off point T=4 h is driven by clinical reasoning I think, like the arguments in the linked presentation?
I worry that the sentence in the Q&A calls for a cut point that is solely driven by the separation of the two phases in the concentration time courses. This would lead in the example courses you have given to T somewhere between 2-3h.
But eventually I'm too anxiety psychotic regarding taking guidances literally
(me sitting in front of a snake).
Thanx for that answer. Elaborate and concise as always.
❝ ... ‘partial Cmax’ (hey – a new term!)
Excerpt from my next report: "We have evaluated the partial Cmax according to Schütz ..." ❝ It might well be that a couple of subjects show a tmax,0-4 at 4 h despite there was a decrease from an earlier peak or there is no clearly defined peak in one of the two sections at all.
In the extremal case this would mean that the Cmax values are the same in both phases! See the red curve of your example picture.
❝ would be nice to know how these guys deal with it.
Me too.
❝ ❝ BTW: I can't see any return of clinical reasoning in the EMA Q&A.
❝ ❝ "The identification of this cut-off time point should aim to describe the plasma concentrations in the first phase ... 
".
❝
❝ Hhm. I don’t get your point here. Can you elaborate?
Your cut-off point T=4 h is driven by clinical reasoning I think, like the arguments in the linked presentation?
I worry that the sentence in the Q&A calls for a cut point that is solely driven by the separation of the two phases in the concentration time courses. This would lead in the example courses you have given to T somewhere between 2-3h.
But eventually I'm too anxiety psychotic regarding taking guidances literally
(me sitting in front of a snake).—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- EMA: Q&A on biphasic MR products Helmut 2012-03-06 15:23 [BE/BA News]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA: Q&A on biphasic MR products ElMaestro 2012-03-06 19:09
- EMA: Q&A on biphasic MR products Helmut 2012-03-07 03:52
- EMA: Q&A on biphasic MR products ElMaestro 2012-03-07 19:20
- EMA: Q&A on biphasic MR products Helmut 2012-03-07 03:52
- EMA vs. FDA d_labes 2012-03-07 10:26
- MPH examples Helmut 2012-03-07 14:22
- MPH examplesd_labes 2012-03-07 16:18
- MPH examples Helmut 2012-03-08 01:07
- FDA more straight? d_labes 2012-03-08 08:29
- and what about power? ElMaestro 2012-03-08 11:37
- and what about power? d_labes 2012-03-08 13:26
- and what about power? Helmut 2012-03-08 13:36
- FDA more straight? Helmut 2012-03-08 12:51
- FDA more straight? luvblooms 2012-03-09 06:55
- Multiphasic MR ≠ DR Helmut 2012-03-09 12:18
- Multiphasic MR ≠ DR jag009 2012-03-28 15:29
- Metadate CD (30/70) Helmut 2012-03-28 15:45
- Multiphasic MR ≠ DR jag009 2012-03-28 15:29
- Multiphasic MR ≠ DR Helmut 2012-03-09 12:18
- FDA more straight? luvblooms 2012-03-09 06:55
- and what about power? ElMaestro 2012-03-08 11:37
- FDA more straight? d_labes 2012-03-08 08:29
- MPH examples Helmut 2012-03-08 01:07
- MPH examplesd_labes 2012-03-07 16:18
- MPH examples Helmut 2012-03-07 14:22
- EMA: Q&A on biphasic MR products ElMaestro 2012-03-06 19:09
Ing. Helmut Schütz