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    Mar 4, 2021
      |  Video

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

    Santos GML
    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

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

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