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Hi Angus,
From the top of my head: Yes, I agree, the residual listings are not essential for FDA submission. But please also check the SAP, it may dictate what a relevant output is, then check your Study Report SOP which may dictate which listings go into your study report.
FDA's reviewers will likely re-calculate the dataset to check if they can obtain the reported CIs.
❝ 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
From the top of my head: Yes, I agree, the residual listings are not essential for FDA submission. But please also check the SAP, it may dictate what a relevant output is, then check your Study Report SOP which may dictate which listings go into your study report.
FDA's reviewers will likely re-calculate the dataset to check if they can obtain the reported CIs.
- If they can then all is good, then it means there is agreement between you and FDA about the residuals since these determine the width of the CI.
- If they can't (and their result is not very close to your result) then you'll get a question about it regardless of whether or not you presented a list of residuals.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
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 Bioequivalence AngusMcLean 2014-03-02 20:40
- Output In Phoenix WinNonlin BioequivalenceElMaestro 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 Bioequivalence AngusMcLean 2014-03-02 20:40
- Output In Phoenix WinNonlin Bioequivalence ElMaestro 2014-03-02 18:28
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