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