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RegisterBE assessment regarding first time point Cmax [Study Assessment]
Dear Ohlbe,
Thank you for your detailed clarification.
Could you please share your views and suggestions from US-FDA and ICH perspective?
Best regards,
Mann
Thank you for your detailed clarification.
Could you please share your views and suggestions from US-FDA and ICH perspective?
Best regards,
Mann
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 outliers mittyri 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