Model-Integrated Evidence for Generic Drug Development – Session 1A
Model-Integrated Evidence for Generic Drug Development – Session 1C
Model-Integrated Evidence for Generic Drug Development – Session 1B
Using MIDD and Model Integrated Evidence to Support Generic Drug Development and Assessment
A Deep Dive: FDA’s Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs
Model-Informed and Model-Integrated Approach in BE Assessment of Long-Acting Injectable Products
Generic Industry Challenge Perspectives - GDUFA Science and Research Initiatives Public Workshop
How to Demonstrate Virtual Bioequivalence for Complex Dermal Generic Drugs
Quantitative Methods and Modeling (29of35) Complex Generics – Sep. 25-26, 2019
Cutting Edge Science in Complex Generics
Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 2 – Part 3
Advancing Generic Drug Development Translating Science to Approval Day 1–Session 4 & Closing Remarks
D1,S2A,S5-Best Practices Using Model-Integrated Evidence & Model Master Files for Complex Generics
Advancing Generic Drug Development: Translating Science to Approval, Day One Closing Remarks
Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 2 – Part 2
Global Generic Drug Landscape
Product-Specific Guidances for Complex Generic Drugs
Achieving Virtual Bioequivalence with PBPK in Lieu of Clinical Studies
Unmet needs in regulatory science for generic drugs
2022 Modeling Approaches Workshop Day 1 Welcome, Opening Remarks Session 1/Symposium 1 Presentations
