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RegisterReplicate design studies in Phoenix/WinNonlin [Software]
posted by Helmut 
– Vienna, Austria, 2010-04-09 19:47 (5913 d 05:30 ago) – Posting: # 5068
Views: 22,671
Dear Simon!
Agree with all your points. The original post dealt with Ae0-t; in bioequivalence only NCA is acceptable to regulators – so I was asking the heretic question about extrapolation. But let sleeping dogs lie.
And you are right, in development of an NCE everybody would model anyway.
Well, the post was D. Labes’, not Hermann’s.
I don’t consider it of any importance at all.
We have bigger problems – no mixed effects model in BE according to the new European Guideline. That’s really a problem – right now
Agree with all your points. The original post dealt with Ae0-t; in bioequivalence only NCA is acceptable to regulators – so I was asking the heretic question about extrapolation. But let sleeping dogs lie.
And you are right, in development of an NCE everybody would model anyway.
❝ […] whether there is any benefit to the WNL user / general PK community of Phoenix implementing the extrapolation Herr Doktor Rotter described in TopFit
Well, the post was D. Labes’, not Hermann’s.
I don’t consider it of any importance at all.
We have bigger problems – no mixed effects model in BE according to the new European Guideline. That’s really a problem – right now
I don’t see any possibility to evaluate a replicate design study with PHX/WNL!
Or as our Indian friends use to say: Please correct me if I am wrong.—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Pk parameter: Urine study (WinNonlin) AA 2010-04-07 07:01
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Ae-inf based on rate Helmut 2010-04-07 18:26
- Ae-inf based on rate AA 2010-04-08 14:08
- Amount_ Recovered = Ae(0-t) Helmut 2010-04-08 14:27
- Already a PK-model? H_Rotter 2010-04-08 20:07
- Already a PK-model? Helmut 2010-04-08 20:47
- Dinosaurs solution. d_labes 2010-04-09 09:31
- Youngster's solution Helmut 2010-04-09 17:25
- Some youngsters may be very old d_labes 2010-04-12 09:39
- Youngster's solution Helmut 2010-04-09 17:25
- Dinosaurs solution. d_labes 2010-04-09 09:31
- Already a PK-model? Helmut 2010-04-08 20:47
- Ae-inf based on rate SDavis 2010-04-09 13:10
- Replicate design studies in Phoenix/WinNonlinHelmut 2010-04-09 17:47
- Ae-inf based on rate AA 2010-04-08 14:08
- Ae-inf based on rate Helmut 2010-04-07 18:26
Ing. Helmut Schütz