“…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
Simulations Plus 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.
Full-scale DILIsym consulting projects are customized to each liver safety application based on your goals and can include:
DILIsym® consulting services are available to anyone, whether or not you have access to the DILIsym software. To receive a presentation on how DILIsym can help your organization, and a custom quote for the perfect project for you, please Contact Us.
There are multiple examples of applications of DILIsym use to support liver safety assessments in clinical drug development. They include:
If your organization already has access to the DILIsym software platform, our DILIsym Discovery Support Program (DDSP) could be the perfect catalyst for your internal simulation program. Access to DILIsym and the DDSP is included with membership in the DILI-sim Initiative.
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.
