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Registerregulatory reasons to consider the study inadequate [Study Assessment]
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In the appendix of The Guideline on the Investigation on Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1) there is a Table 3.2 Additional pharmacokinetic data for <analyte> in <study ID>, where it is supposed to put information about the records where Cmax is the first point (as well as records where AUC0-t/AUC0-∞<0.8 and records where pre-dose sample > 5% Cmax). Could the regulators ban the results of the BE study with such data? Did you ever faced with this in your practice? What was the percentage of subjects with such data (for example for 0.8 it is common to suppose more than 20%)? If there is only one or two subjects with Cmax in the first point should we perform additional analysis excluding them in order to show that this doesn't affect the results if it was not stated in the protocol?
Edit: Appendix IV linked. [Helmut]
In the appendix of The Guideline on the Investigation on Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1) there is a Table 3.2 Additional pharmacokinetic data for <analyte> in <study ID>, where it is supposed to put information about the records where Cmax is the first point (as well as records where AUC0-t/AUC0-∞<0.8 and records where pre-dose sample > 5% Cmax). Could the regulators ban the results of the BE study with such data? Did you ever faced with this in your practice? What was the percentage of subjects with such data (for example for 0.8 it is common to suppose more than 20%)? If there is only one or two subjects with Cmax in the first point should we perform additional analysis excluding them in order to show that this doesn't affect the results if it was not stated in the protocol?
Edit: Appendix IV linked. [Helmut]
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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