Incurred Sample Reanalysis

Purpose and Regulatory Basis Incurred sample reanalysis involves the re-analysis of a defined subset of actual study samples, containing drug arising from...

Purpose and Regulatory Basis

Incurred sample reanalysis involves the re-analysis of a defined subset of actual study samples, containing drug arising from genuine in vivo dosing rather than spiked reference standard, in order to confirm the reproducibility of the bioanalytical method under real-world conditions that include authentic metabolites, co-administered medications, and matrix characteristics specific to the dosed subject population. Unlike quality control samples prepared by fortifying blank matrix, incurred samples cannot be perfectly replicated, and their reanalysis therefore provides a uniquely rigorous test of method robustness. Incurred sample reanalysis is mandated by the United States Food and Drug Administration, the European Medicines Agency, and International Council for Harmonisation guideline M10 for all pivotal pharmacokinetic and bioequivalence studies, with results generally required to agree with the original determination within twenty percent for at least two-thirds of the reanalysed samples.