Drug-induced liver injury (DILI) or hepatotoxicity have consistently been a leading cause of drug withdrawal from the market over the past decades. While technology has been evolving to provide better predictions for DILI risk even in pre-clinical stages, DILI still remains a major concern for drug developers and regulators.
The complexity of DILI further complicates strategies for hepatotoxicity de-risking. Liver toxicity may be acute or chronic, dose-dependent or idiosyncratic, and result in a wide range of clinical representations from hepatic necrosis through hepatocellular hepatitis to different types of cholestasis. How can we differentiate between the different DILI mechanisms? And more importantly, how can we “de-risk” a toxicity with no unified defining criteria?
We start this webinar with an overview of the complexities of DILI, then discuss how to build a de-risking plan based on current mechanistic knowledge. We emphasize the importance of incorporating hepatotoxicity de-risking in the early stage of drug development and how this can help risk management and data-driven decision making. We talk about key risk factors and red flags and take a look at the various tools available, including in silico, in vitro and in vivo, focusing on their application and predictive value to support the development of drugs that are both efficacious and safe. Sign up top learn how to “liver-proof” your drug.
RegisterKey Learning Objectives
- Understand the importance and complexity of drug-induced liver injury
- Discover how a stepwise DILI de-risking strategy can be adapted to individual pre-clinical development projects
- What key drug design strategies, in silico tools, and in vitro/in vivo assays can be used to address DILI-risk
- How to choose the right experiments to support data-driven decision-making
