"…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. uses DILIsym® to generate simulation-based analyses that support decision making throughout the clinical development pipeline. The unique analyses can provide a better understanding of the potential liver safety risks associated with a compound. In addition to making predictions of liver toxicity for compounds in clinical development, DILIsym® has also been applied to provide an enhanced understanding of liver injury biomarker signals in clinical trials.
Simulation analyses with DILIsym® have been included in multiple communications with regulatory agencies.
DILIsym Services also provides mechanistic in vitro data collection in house and via partnerships.
There are multiple examples of applications of DILIsym® to support liver safety assessments in clinical drug development. They include:
- Predicting preclinical in vivo and clinical hepatotoxicity using in vitro data inputs
- Predicting rare or idiosyncratic DILI in late-stage clinical trials
- Predicting species differences in translating preclinical DILI safety data to Phase I clinical trials
- Determining severity of liver injury by using DILIsym® to analyze clinical biomarkers
- Selecting of dosing paradigm based on liver safety risks
- Identifying DILI mechanisms and susceptibility factors associated with a compound