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

Authors: Lukacova V
Keywords: absorption, biowaivers, Food effects, In vitro in vivo correlations (IVIVC), in vivo, PK
Software: GastroPlus®
Division: Simulations Plus

Outline

  • 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