Predicting idiosyncratic drug-induced liver injury – some recent advances

Abstract

Drug-induced liver injury (DILI) is a major challenge for the pharmaceutical industry, regulatory authorities, and clinicians. It is usually categorized into ‘intrinsic’ and ‘idiosyncratic’, but DILI caused by most drugs is of an idiosyncratic nature and usually cannot be predicted from the regulatory required animal toxicity studies. Unfortunately, some individuals exposed to therapeutic dose will develop idiosyncratic DILI that might involve severe clinical outcome, and no biomarker is available to identify the susceptible patients prior to drug treatment. In this editorial, we summarized the recent advances in predicting idiosyncratic DILI and provided the perspectives to improve the prediction.

Keywords::

• data integration
• drug safety
• HLA
• idiosyncratic drug-induced liver injury
• predictive model

Disclaimer

The views presented in this article do not necessarily reflect those of the US FDA.

Financial & competing interests disclosure

J Borlak receives funding from the German Federal Ministry for Education and Research as part of the Virtual Liver Network initiative (Grant number 031 6154). Furthermore, J Borlak is recipient of an ORISE Stipend of the US FDA which is gratefully acknowledged. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.