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

Working Groups

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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


Immunotherapy

 

Biomarkers

 

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