The role of modeling and simulation in the approval of generic drug products

Authors: Santos GML
Conference: SLP MIDD+
Keywords: generic drug products, modeling and simulation, Post-Approval/Generics, SLP2021MIDD

Brazilian Regulatory Structure

  • Positive Law
  • Resolutions, Normative Instructions and Guides
  • Generality versus Detailing
  • Pharmacometrics: no specific requirement

By Gustavo Mendes Lima Santos

Download Slides

Presented at SLP MIDD+ Virtual Conference March 3-4, 2021