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

Abstract

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 because traditionally many laboratories have always utilized acceptance criteria to "pass" or "fail" the study. This editorial discusses how bioanalytical labs should conduct cross-validation for PK assays post-ICH M10, highlighting the role of statistical methods and the need for close collaboration with clinical pharmacology and biostatistics departments. Proper implementation and strategic focus on relevant studies are essential for effective cross-validation.