Drug-Induced Liver Injury (DILI) Consulting Services for Clinical Development

The liver is the primary site for drug metabolism and biotransformation. As such, it is particularly susceptible to injury from drugs and their reactive metabolites. Drug-induced liver injury (DILI) remains one of the most common, yet challenging adverse events encountered during drug development. DILI is a leading cause of pipeline attrition, regulatory review delays, clinical holds, restrictive labeling, post-marketing warnings, and market withdrawals.

If not identified early, DILI may progress rapidly, and while rare, can result in acute liver failure, liver transplantation, or death. No single laboratory test confirms DILI. Thus, effective liver safety assessment requires more than routine monitoring of aminotransferases [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)].  It demands an integrated strategy that combines careful decisions on protocol eligibility and design, baseline risk assessment, appropriate laboratory surveillance, temporal association with study drug exposure, standardized evaluation of liver test elevations, exclusion of alternative etiologies, structured causality assessment, and timely regulatory decision-making. This systematic approach should balance patient safety with the advancement of therapeutic innovations.

Dr. Melissa Palmer, a renowned international expert in liver safety, with over 40 years of Hepatology experience, provides comprehensive insights and strategies to navigate the challenges of DILI, ensuring optimal patient outcomes while advancing medical understanding in this critical area.