The diagnosis of idiosyncratic drug-induced liver injury (DILI) is a challenging task
due to the lack of specific features or definitive diagnostic tools. A minimum of clinical
and pharmacological information is required, together with laboratory and imaging
tests to exclude other causes of liver injury. Several standardized methods have
been developed to support clinical judgement and establish causality assessment, the
most widely used being the Roussel Uclaf Causality Assessment Method—RUCAM—
and structured Expert Opinion. More recently, an evidence-based,
revised RUCAM, Electronic Causality Assessment Method—RECAM—has been developed and, although
still a work in progress, may replace RUCAM scoring in the future. International
collaborative networks and ongoing research efforts are key to advancing biomarker
qualification and validation and developing new in vitro patient-based
methods that will help improve DILI diagnosis and move towards a personalized medicine approach.