Incorporating Mechanistic Modeling & Simulation to Assist with Formulation Development and Regulatory Evaluations

Authors: Lukacova V
Software: GastroPlus®
Division: PBPK


  • Why Modeling & Simulation?
  • Overview of Mechanistic Simulation Models
    • Predicting in vivo absorption & PK
  • Applications in Generic Product Development
    • Generating IVIVCs
    • Performing virtual bioequivalence trials and establishing dissolution specifications
    • Understanding food effects
  • A successful biowaiver case study
  • Conclusions

By Viera Lukacova