Related Experiment Video
Updated: Jan 18, 2026

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
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.
Abstract:
The 13th GCC Closed Forum for Bioanalysis was held in New Orleans, Louisiana, USA on April 5th, 2019. This GCC meeting was organized to discuss the contents of the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline published in February 2019 and consolidate the feedback of the GCC members. In attendance were 63 senior-level participants from eight countries representing 44 bioanalytical CRO companies/sites. This event represented a unique opportunity for CRO bioanalytical experts to share their opinions and concerns regarding the ICH M10 Bioanalytical Method Validation Draft Guideline and to build unified comments to be provided to the ICH.
More Related Videos
Related Concept Videos
Data Validation
Key parameters for method validation include:
In Vitro Drug Release Testing: Overview, Development and Validation
Development of Analytical Methods
Bioequivalence: Overview
Bioequivalence studies: Biowaivers

