Incorporating Mechanistic Modeling & Simulation to Assist with Formulation Development and Regulatory Evaluations
Keywords: absorption, biowaivers, Food effects, In vitro in vivo correlations (IVIVC), in vivo, PKSoftware: 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
