Whole blood stability in bioanalytical method validation: updated recommendations from the European Bioanalysis Forum

This paper discusses the updated recommendations from the European Bioanalysis Forum on whole blood stability testing in bioanalytical method validation. The recommendations are based on EBF community feedback on the ICH M10 guidelines and associated training materials. The ICH M10 guidelines highlight the importance of assessing analyte stability throughout the lifecycle of the sample, including in whole blood, immediately after collection, to ensure that the analyte concentration in the tested sample accurately reflects the concentration at the time of collection. Aspects considered in these recommendations are the definition of fresh blood, equilibration times, assay type and how the experiments can be conducted to align with the 3Rs principles.