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RegisterPublication of the final ICH M10 guideline [BE/BA News]
» The ICH M10 guideline "Bioanalytical method validation and study sample analysis" has been adopted on 24 May 2022 and published on the ICH web site.
Thank you Mr. Ohlbe for the update.
Dear Members,
The ICH guidelines asks for 100% of chromatograms to be submitted. As per EMA and USFDA requirements Chromatograms from 20% of subjects are required.
Should we start submitting 100% chromatograms now.
Regards
Thank you Mr. Ohlbe for the update.
Dear Members,
The ICH guidelines asks for 100% of chromatograms to be submitted. As per EMA and USFDA requirements Chromatograms from 20% of subjects are required.
Should we start submitting 100% chromatograms now.
Regards
Complete thread:
- Publication of the final ICH M10 guideline Ohlbe 2022-06-10 10:48 [BE/BA News]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Publication of the final ICH M10 guidelinequalityassurance 2022-06-12 12:31
- Chromatograms Ohlbe 2022-06-14 11:37
- Publication of the final ICH M10 guidelinequalityassurance 2022-06-12 12:31
Ing. Helmut Schütz