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GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline
Corey Nehls1, Michael Buonarati2, Stephanie Cape3
1PPD Laboratories, Richmond, Virginia, USA.
Bioanalysis
|October 1, 2019
Summary
The 13th GCC Closed Forum for Bioanalysis convened experts to discuss the 2019 ICH M10 Draft Guideline on bioanalytical method validation. Participants shared concerns and consolidated feedback for unified comments to the International Council for Harmonisation.
Area of Science:
- Bioanalytical Chemistry
- Pharmaceutical Analysis
- Regulatory Science
Background:
- The International Council for Harmonisation (ICH) released the M10 Draft Guideline for Bioanalytical Method Validation in February 2019.
- The 13th GCC Closed Forum for Bioanalysis provided a platform for industry experts to review this draft guideline.
Purpose of the Study:
- To discuss the specific contents of the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline.
- To consolidate feedback and concerns from bioanalytical Contract Research Organization (CRO) experts.
- To formulate unified comments for submission to the ICH.
Main Methods:
- A closed forum meeting format was utilized.
- Discussions involved senior-level participants from bioanalytical CROs.
- Feedback was gathered through expert deliberations.
Main Results:
- Sixty-three senior bioanalytical experts from 44 CROs/sites across eight countries attended.
- Opinions and concerns regarding the ICH M10 draft guideline were shared.
- A consensus was built for unified comments.
Conclusions:
- The forum successfully facilitated a collaborative review of the ICH M10 draft guideline.
- Consolidated expert feedback is intended to inform the final ICH M10 guideline.
- This meeting highlighted the importance of CRO input in regulatory guideline development.
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