Roadmap for drug-induced liver injury

Published on

3D Illustration of Human Body illustrating the liver

The liver is one of the organs most susceptible to drug toxicity, and in the clinic, drug-induced liver injury (DILI) has accounted for more than 50% of acute liver failure cases. Excluding acetaminophen, DILI accounts for approximately 14% of acute liver failures with a mortality rate of up to 10%. DILI is also a major cause of drug attrition, leading to withdrawal of potentially valuable therapies during preclinical testing, clinical trials and post-marketing. 

It is clear that current preclinical testing paradigms based on a combination of various in vitro and in vivo models are poorly predictive, at a quantitative and mechanistic level, of the potential for a new drug candidate to cause DILI in humans, in particular those drugs that show poorly defined dose–response relationships and/or human-specific mechanisms of toxicity.

This new Perspective presents our vision for a DILI roadmap, with the aim of managing DILI risk and, ultimately, assisting in the design and development of safer and more effective medicines. Our approach comprises a tiered system, which integrates established and emerging cell-based technologies into a coherent map for drug development and, ultimately, for drug regulation.

Click here to read the paper. 

Researchers affiliated with the MRC Centre for Drug Safety Science have published more than 700 peer-reviewed journal articles that have made significant contribution to the relevant academic disciplines. For more publications from CDSS scientists and their collaborators, please visit our Publications pages.