IQ Consortium Drug-Induced Liver Injury Initiative: An Affiliate of the International Consortium for Innovation and Quality in Drug Development

Working Groups


The working groups in the IQ-DILI Initiative are conducting industry benchmarking and actively engaged in work on white papers on topics related to the management and prevention of DILI. The working groups are focused on:


Abnormal Baselines


Monitoring and assessment of potential DILI in patients with abnormal hepatic biochemical tests at baseline

Causality Assessment

Causality assessment in all patterns of DILI (hepatocellular, cholestatic, hepatic steatosis, vascular) and best practices for drug re-challenge





Nonclinical Translation


Risk Mitigation and Pharmacovigilance



Immune-related liver injury due to immunotherapy, such as checkpoint inhibitors

Development of clinical best practices to investigate emerging, potentially translational biomarkers for the assessment of DILI

Adjustments in monitoring and assessment of DILI during clinical trials based on nonclinical toxicology findings

Post-marketing pharmacovigilance programs and Risk Evaluation and Mitigation Strategies (REMS) for DILI

Unique aspects of monitoring for, diagnosing, managing, and preventing DILI in clinical trials and in post-marketing pharmacovigilance activities in the pediatric, including neonatal, population