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RegisterOutput In Phoenix WinNonlin Bioequivalence [Software]
Thank for your remarks: it seems that you have a good knowledge of this bizarre field. SAS is of course a major program here; they are 600 miles from here in North Carolina. I had a small version of the program a while ago. Since the study is not a balanced study, on account of a dropout subject, I will then submit both. Why?
The fear is of the FDA asking for additional information; if you only file one partial or sequential then they ask for the other..................delays the review. That is why submitting both is pursued.
On that note:
Additionally Phoenix WinNonlin provides values for the model-predicted PK parameters (by the regression matrix approach) and then provides observed values and the residuals in a Table. I am not planning on submitting this information. Do you agree? I do not think it is relevant to bio equivalence
Angus
The fear is of the FDA asking for additional information; if you only file one partial or sequential then they ask for the other..................delays the review. That is why submitting both is pursued.
On that note:
Additionally Phoenix WinNonlin provides values for the model-predicted PK parameters (by the regression matrix approach) and then provides observed values and the residuals in a Table. I am not planning on submitting this information. Do you agree? I do not think it is relevant to bio equivalence
Angus
Complete thread:
- Output In Phoenix WinNonlin Bioequivalence AngusMcLean 2014-03-02 18:01
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Output In Phoenix WinNonlin Bioequivalence ElMaestro 2014-03-02 18:28
- Output In Phoenix WinNonlin BioequivalenceAngusMcLean 2014-03-02 20:40
- Output In Phoenix WinNonlin Bioequivalence ElMaestro 2014-03-02 21:25
- Output In Phoenix WinNonlin Bioequivalence AngusMcLean 2014-03-04 20:55
- Output In Phoenix WinNonlin Bioequivalence ElMaestro 2014-03-04 21:42
- Output In Phoenix WinNonlin Bioequivalence AngusMcLean 2014-03-05 02:59
- Output In Phoenix WinNonlin Bioequivalence Ohlbe 2014-03-05 08:18
- Output In Phoenix WinNonlin Bioequivalence AngusMcLean 2014-03-05 21:29
- Output In Phoenix WinNonlin Bioequivalence ElMaestro 2014-03-05 16:02
- Output In Phoenix WinNonlin Bioequivalence AngusMcLean 2014-03-05 21:31
- Output In Phoenix WinNonlin Bioequivalence Ohlbe 2014-03-05 08:18
- Output In Phoenix WinNonlin Bioequivalence AngusMcLean 2014-03-05 02:59
- Output In Phoenix WinNonlin Bioequivalence ElMaestro 2014-03-04 21:42
- Output In Phoenix WinNonlin BioequivalenceAngusMcLean 2014-03-02 20:40
- Output In Phoenix WinNonlin Bioequivalence ElMaestro 2014-03-02 18:28
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