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RegisterFDA and outliers [Study Assessment]
Dear Mann,
I don't think the position of FDA is different.
Please see this old post.
Do you have any experience of BEQ analysis for submission in FDA/EMA jurisdiction?
Where is the idea of outliers coming from?
Do the results without any outliers analysis also show not-BE?
I don't think the position of FDA is different.
Please see this old post.
Do you have any experience of BEQ analysis for submission in FDA/EMA jurisdiction?
Where is the idea of outliers coming from?
Do the results without any outliers analysis also show not-BE?
—
Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- BE assessment regarding first time point Cmax Mann 2018-12-09 10:14 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE assessment regarding first time point Cmax Ohlbe 2018-12-09 23:46
- BE assessment regarding first time point Cmax Mann 2018-12-10 00:28
- BE assessment regarding first time point Cmax Ohlbe 2018-12-11 00:05
- FDA and outliersmittyri 2018-12-11 16:38
- BE assessment regarding first time point Cmax Erkin 2018-12-28 08:29
- BE assessment regarding first time point Cmax ElMaestro 2018-12-28 14:32
- BE assessment regarding first time point Cmax Erkin 2018-12-28 20:57
- regulatory reasons to consider the study inadequate Astea 2019-03-02 18:02
- Good question, next question Helmut 2019-03-03 19:42
- first point Cmax: trouble waiting to happen? Astea 2019-03-03 21:42
- Good question, next question Helmut 2019-03-03 19:42
- regulatory reasons to consider the study inadequate Astea 2019-03-02 18:02
- BE assessment regarding first time point Cmax Erkin 2018-12-28 20:57
- BE assessment regarding first time point Cmax ElMaestro 2018-12-28 14:32
- BE assessment regarding first time point Cmax Mann 2018-12-10 00:28
- BE assessment regarding first time point Cmax Ohlbe 2018-12-09 23:46
Ing. Helmut Schütz