Cross-validation plays a crucial role in ensuring data exchangeability throughout bioanalytical assay life cycle across different methods or laboratories. The ICH M10 guidance addresses gaps from previous guidelines concerning the conduct and data analysis of cross-validation studies. While the guidance provides high-level direction, it allows flexibility for sponsors to implement their own statistical analysis and acceptance criteria. A statistically based data analysis strategy was developed at GSK, which defined the statistical methods, assessment parameters, and reference values for cross-validation determination. The integrated statistical methodology provided a rigorous and informative framework for assessing method variability.
Learning Objectives:
Upon completion, participants will be able to understand GSK’s approach to implementing the ICH M10 guidance for bioanalytical cross-validations.
Upon completion, participants will be able to comprehend the experimental conduct of cross-validations at GSK.
Upon completion, participants will be able to understand the statistical parameters and reference values used at GSK for cross-validation data analysis.
Upon completion, participants will be able to share their opinions and discuss good practices for bioanalytical cross-validation.
