Conference Report from the European Bioanalysis Forum Workshop: toward harmonized implementation of the ICH M10 guideline

In this report, the European Bioanalysis Forum shares the proposals for harmonized implementation of the ICH M10 guideline on bioanalytical method validation and study sample analysis from the ICH M10 workshop. The focus of the discussions was to understand new, changed or still ambiguous regulatory...

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Bibliographic Details
Published inBioanalysis Vol. 14; no. 22; pp. 1407 - 1411
Main Authors Timmerman, Philip, Barfield, Matthew, Cowan, Kyra, Ferrari, Luca, Golob, Michaela, Goodman, Joanne, Kall, Morten, Laurén, Anna, Love, Iain, McDougall, Stuart, Nelson, Robert, Pynaert, Gwenda, Staack, Roland F, Verhaeghe, Tom, White, Steve
Format Journal Article
LanguageEnglish
Published England Newlands Press Ltd 01.11.2022
Subjects
conference report
European Bioanalysis Forum
guidelines
ICH M10
Industry
method validation
Research Design
Research Report
method validation
guidelines
ICH M10
conference report
European Bioanalysis Forum
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Summary:In this report, the European Bioanalysis Forum shares the proposals for harmonized implementation of the ICH M10 guideline on bioanalytical method validation and study sample analysis from the ICH M10 workshop. The focus of the discussions was to understand new, changed or still ambiguous regulatory expectations in the guideline, as identified in feedback from the pre-workshop surveys or during the workshop. The proposals from the workshop aim at stimulating and helping a harmonized implementation of the guideline, and using our community as a sounding board during and after implementation to highlight areas of misalignment and to create a platform for continued sharing with the regulatory authorities in an effort to contribute to industry and regulators developing similar interpretations on guideline expectations.
ISSN:1757-6180
1757-6199
DOI:10.4155/bio-2022-0229