Thresholds of biomarkers for skipping histopathological examination of the liver in mice

Abstract

Histopathological examination is time-consuming despite its critical role in toxicological evaluation. In this ROC analysis for 4-day screening mouse studies, we identified the thresholds for the biomarkers such as AST, ALT and bilirubin, which convinced us of the toxicologically significant liver damage without histopathological examination. Combination of the biomarkers was more predictive than each biomarker alone. In conclusion, these thresholds enable us to judge toxicological significance in agile way at early screening phase of drug development.