The role of modeling and simulation in the approval of generic drug products
Keywords: generic drug products, modeling and simulation, Post-Approval/Generics, SLP2021MIDDConference: SLP MIDD+
Brazilian Regulatory Structure
- Positive Law
- Resolutions, Normative Instructions and Guides
- Generality versus Detailing
- Pharmacometrics: no specific requirement
By Gustavo Mendes Lima Santos
Presented at SLP MIDD+ Virtual Conference March 3-4, 2021