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

Authors: Santos GML
Conference: SLP MIDD+

Brazilian Regulatory Structure

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

By Gustavo Mendes Lima Santos

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