Use of a Quantitative Systems Pharmacology (QSP) Model to Predict Liver Toxicity in Simulated Populations

Authors: Battista C
Conference: WPC
Keywords: biomarker, dose selection, drug-induced liver injury, hepatotoxicity, pharmaceutical, risk assessment
Software: DILIsym®
Division: Quantitative Systems Pharmacology (QSP)

DILIsym Summary

  • DILIsym is a mechanistic, mathematical model that has been constructed to support pharmaceutical risk assessment and decision making
    • Intersection of compound distribution and metabolism (PBPK), hepatotoxicity mechanisms, and patient variability
    • Core focus on explaining and predicting drug-induced liver injury (DILI)
  • 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
  • DILIsym simulation results have been included in over fifteen communications with regulatory agencies

World Preclinical Congress Europe, November 27-30, 2018, Libson, Portugal

By Christina Battista