Despite extensive research and considerable progress in recent decades, drug-induced liver injury (DILI) remains a major concern for patients, health care providers, and drug makers. Early prediction, diagnosis, and assessment of DILI during drug development continue to present major challenges to the drug industry, and hepatic safety concerns remain a leading cause for aborted development of new drugs. Presently, most drug makers rely during drug development on regulatory guidelines, position papers by various expert groups,3–6and consultation with external experts.

-