Cross-validation of pharmacokinetic assays post-ICH M10 is not a pass/fail criterion

Fjording MS, Goodman J & Briscoe C | Bioanalysis, 17(01), 1–5, (2024) Keywords: • chromatography • cross-validation • ICH M10 • ligand binding assay • PK assay • regulatory • validation The ICH M10 guideline establishes global standards for bioanalytical method validation for pharmacokinetic assays, focusing on data reliability and accuracy across studies. A significant component is cross-validation, which should be performed to ensure data comparability when multiple methods or laboratories are involved in a single study or across studies where comparison will be performed. However, ICH M10 does not specify acceptance criteria for cross-validation, creating challenges for the industry...