01. Discover

Mechanistic Interpretation of Observed Safety Signals… and Predictions for Reducing Risk of Future Events

“…the introduction of new measurement technologies and increasing knowledge about toxicity mechanisms and pathways offer important opportunities for advanced computational analyses that can promote the effective translation of nonclinical findings to the clinical setting.” – Advancing Regulatory Science at FDA, August 2011

DILIsym Services Inc., a Simulations Plus Company, offers quantitative systems toxicology (QST) consulting services using our DILIsym software for the mechanistic understanding and prediction of drug-induced liver injury (DILI) events in humans, dogs, rats, and mice.  DILIsym, with multiple mechanisms of liver toxicity (bile acid transporter inhibition (e.g., BSEP), mitochondrial toxicity, oxidative stress, lipotoxicity), has features and capabilities to support investigation of liver safety in most phases of drug development: lead candidate selection, preclinical toxicology, first-in-human safety, later clinical trial safety, and post-marketing.  Simulation analyses with DILIsym have been included in multiple communications with regulatory agencies.

02. Explore
Example applications of DILIsym

Check out our YouTube videos below discussing example applications of DILIsym to see the POWER and POTENTIAL of mechanistic safety modeling for your development pipeline.