Hepatotoxicity
Hepatotoxicity Studies
Supporting Lead Selection and Optimization with Actionable Liver Safety Data
Additionally, hepatotoxicity evaluations are used to determine the dose range for other in vitro ADME studies. As part of our comprehensive portfolio of ADME-Tox research services we provide the following hepatotoxicity studies.
Cholestatic Tox Assessment
Assess the risk of cholestatic liver injury using the C-DILI™ Assay Tox Assessment—a specialized in vitro model designed to detect bile acid transporter disruptions and cholestasis-related toxicity
Mechanistic Tox Assays
Mechanistic toxicity assays use in vitro models to explore how test articles induce specific toxic effects, helping uncover underlying cellular pathways and mechanisms.
Predictive Hepatotoxicity Assays
In vitro predictive hepatotoxicity assays evaluate the potential liver toxicity of test articles and support early dose range determination for downstream in vitro studies.
Depending on the characteristics of the compounds being investigated and the research objectives we recommend different model systems for hepatotoxicity studies including conventional suspension or plated hepatocytes, TRANSPORTER CERTIFIED™ hepatocytes in sandwich culture if efflux transporters play a critical role in drug disposition, or HEPATOPAC® Cultures for low turnover compounds.
Drug induced liver injury (DILI) is one of the leading causes of adverse events during clinical trials, which often results in failures or clinical holds during the development of new drug candidates. However, several mechanisms of DILI have been well-characterized and they can be evaluated in a non-clinical setting or with in vitro tools. In vitro hepatotoxicity assays are cell-based experiments that yield data which when considered all together in a comprehensive ‘risk matrix’, can help a drug developer assess risk of liver injury by exploring different mechanisms that could impair hepatic function.