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Registerfirst point Cmax: trouble waiting to happen? [Study Assessment]
Dear Helmut!
Thank you very much for your response!
That's understandable that the sampling schedule should be planned to avoid Cmax being the first point. But if it has just happened for some (or even for the majority) subjects? "It happens... sometimes" (Forrest)
Can assessors ban the whole study for this reason? So far I was lucky enough not to get any questions from russian assessors, but we are planning to deal with the regulators from other countries. Contrary to the Mann's situation the full data set is BE. I would like to know if there were any precedents of this kind.
Thank you very much for your response!
That's understandable that the sampling schedule should be planned to avoid Cmax being the first point. But if it has just happened for some (or even for the majority) subjects? "It happens... sometimes" (Forrest)
❝ My personal summary: First-point Cmax “should be avoided”. Though not elaborated in the section about exclusion, I would state it in the protocol. See also what Ohlbe wrote above. I would gather that excluding >20% of subjects will lead to troubles (similar to high residual AUC).
Can assessors ban the whole study for this reason? So far I was lucky enough not to get any questions from russian assessors, but we are planning to deal with the regulators from other countries. Contrary to the Mann's situation the full data set is BE. I would like to know if there were any precedents of this kind.
—
"Being in minority, even a minority of one, did not make you mad"
"Being in minority, even a minority of one, did not make you mad"
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