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Editorial
. 2025 Jan;17(1):1-5.
doi: 10.1080/17576180.2024.2418284. Epub 2024 Nov 6.

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

Marianne Scheel Fjording  1 , Joanne Goodman  2 , Chad Briscoe  3
Affiliations
Editorial

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

Marianne Scheel Fjording et al. Bioanalysis. 2025 Jan.

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.

Keywords: ICH M10; PK assay; chromatography; cross-validation; ligand binding assay; regulatory; validation.

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Conflict of interest statement

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

References

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