Using DILIsym, A Quantitative Systems Toxicology (QST) Software Tool of Drug-Induced Liver Injury (DILI), To Assess DILI Risk in Drug Development

Authors: Howell BA
Conference: BIT IDDST
Keywords: drug discovery, drug induced liver injury (DILI), in silico modeling, risk assessment
Software: DILIsym®
Division: Quantitative Systems Pharmacology (QSP)

Presentation Summary

  • A combination of multiple mechanistic, in silico modeling approaches can facilitate drug discovery (QSAR, PBPK, QSP and QST)
  • DILIsym is a mechanistic, mathematical model that has been constructed to support pharmaceutical risk assessment and decision making
  • DILIsym simulation results have been included in numerous communications with regulatory agencies
  • DILIsym has been applied to support decisions related to compound DILI risk throughout the clinical development pipeline
    • Evaluated and interpret clinical biomarker signals in clinical trials
    • Optimized clinical trial design (dose selection, monitoring, inclusion/exclusion criteria)
    • Translated preclinical safety risk to first in human clinical trials
    • Ranked compounds by risk

BIT’s 16th Annual Congress of International Drug Discovery Science and Technology-2018, August 16-19, 2018, Cambridge, MA

By Brett A Howell