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RegisterMarginally failed study for Europe [Study Assessment]
Hi,
I have conducted a full replicate BE study for one of the highly variable product for Europe regulatory.
Based on the reference product variability, relaxed 90% Confidence Intervals is 75.18 to 133.01 for Cmax.
Study marginally failed with 90% upper CI data of 133.18
Is there any way to justify Europe regulatory authority(ies) to accept this study data? (DCP submission)
Regards
Edit: Category changed; see also this post #1 and #4. [Helmut]
I have conducted a full replicate BE study for one of the highly variable product for Europe regulatory.
Based on the reference product variability, relaxed 90% Confidence Intervals is 75.18 to 133.01 for Cmax.
Study marginally failed with 90% upper CI data of 133.18
Is there any way to justify Europe regulatory authority(ies) to accept this study data? (DCP submission)
Regards
Edit: Category changed; see also this post #1 and #4. [Helmut]
Complete thread:
- Marginally failed study for Europebalakotu 2018-04-24 07:30 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Marginally failed study for Europe Yura 2018-04-24 12:31
- Upper 90% CL 0.17% > U Helmut 2018-04-29 23:46
Ing. Helmut Schütz