Applying Physiologically-Based Pharmacokinetic (PBPK) Modeling & Simulation to Assist with Pharmaceutical Research and Regulatory Submissions

Authors: Morris D
Conference: CERSI
Keywords: drug inputs, Physiologically based pharmacokinetic (PBPK) modeling, regulatory submission, United States Food and Drug Administration
Software: GastroPlus®
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Introduction

  • Open communication between regulatory agencies, pharmaceutical companies, universities, and software providers will help identify new M&S applications:
    • Food effect modeling
    • Disease state populations
    • Oral/non-oral delivery of drug products – virtual BE
  • FDA is increasing funding to scientists from across the world to
    ensure that the regulatory review of new chemical entities
    (NCEs) and generic drugs is based on the best available science

    • Will other regulatory agencies follow?
  • FDA and EMA have developed first guidance documents
    for the application of PBPK simulation in submissions.

Center for Excellence in Regulatory Science, University of Maryland, Baltimore

By Denise Morris