Prediction of Drug Induced Liver Disease, Pre and Post Marketing

Drug induced liver disease is one of the most important causes of drug withdrawals post marketing. The liver is an engine that creates and stores energy, metabolises and detoxifies chemicals through various pathways, each of which can be a target of liver injury. Corroboration with animal studies is not optimal; pre registration studies do not have sufficient numbers to identify injury causing drug candidates, making prediction of liver injury a challenging task. Efforts are on to identify potential hepatic injury causing molecules at the molecular assessment, preclinical, clinical and post marketing stages in a product lifecycle. This article reviews many of these efforts that are ongoing to predict drug induced liver injury