Identification of novel Biomarkers for idiosyncratic drug-induced liver injury by combining MetaHeps® and Proteomics

Background: Drug-induced liver injury (DILI) is the most frequent cause of acute liver failure and the single most important reason for regulatory actions on drugs. In contrast to dose-related hepatotoxicity, idiosyncratic DILI (iDILI) is not predictable by preclinical models. Diagnosis of iDILI relies on the exclusion of other causes for liver injury and it may be impossible to identify the causative agent in polymedication. These difficulties in precise case characterization impede with efficient development of novel iDILI biomarkers. We have developed a method to diagnose or exclude iDILI using hepatocyte-lik…