Using Model Informed Drug Development and Model Integrated Evidence to Support Generic Drug Development and Assessment

Authors: Zhao L
Conference: SLP MIDD+
Keywords: Generic Drug Development, MIDD (model-informed drug development), Model Integrated Evidence, modeling and simulation, Ophthalmic Emulsions, PBPK model, Post-Approval/Generics, Quantitative Methods & Modeling, SLP MIDD+ Virtual Conference, SLP2021MIDD

Liang Zhao, Division of Quantitative Methods & Modeling, Office of Research and Standards, Office of Generic Drugs, CDER, and FDA presents using model-informed drug development and model integrated evidence to support generic drug development assessment.

Topics covered:

  • Quantitative Methods & Modeling (QMM) for Generic Drug Development and Approval
  • Modeling and Simulation Impact Various Regulatory Activities in the Office of Generic Drugs
  • Three case study examples –
    • Using PBPK Modeling to Establish Bioequivalence Dissolution Safe Space for Oseltamivir
    • Recognize Critical Quality Attribute (CQA) for Ophthalmic Emulsions
    • Dermal PBPK Model to Supporting Diclofenac Sodium Topical Gel, 1% Approval
  • and more!

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