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Welcome to Day 2 and Session 5A: Considerations for Demonstrating Bioequivalence for Generic Intravaginal Rings and Intrauterine Systems
Session Chair(s)
Yan Wang, PhD
Acting Team Lead, Division of Therapeutic Performance, ORS, OGD, CDER
FDA, United States
Robert Berendt, PhD
Branch Chief, Division of Immediate & Modified Release Products III, OLDP, OPQ,
FDA, United States
Markham Luke, MD, PhD
Director for Therapeutic Performance, Office of Generic Drugs, CDER
FDA, United States
Welcome to Day 2
Learning Objective : - State the current landscape of IVRs and IUSs in the US market
- Describe current regulatory science and thinking associated with demonstrating bioequivalence for generic IVRs and IUSs
- Explain Q1/Q2 sameness considerations for IVRs and IUSs
- Identify critical quality and design attributes of IVRs and IUSs that should be considered during product development to ensure clinical performance according to the reference listed drug labeling
Speaker(s)
Current Landscape of Approved IVRs and IUSs on the US Market: Overview of Product Designs, Formulations, and Manufacturing Processes
Pinaki Desai, PhD
FDA, United States
Quality Assessor, Office of Lifecycle Products, OPQ, CDER
Bioequivalence of IVRs and IUSs: Current Perspective and Future Directions
Yan Wang, PhD
FDA, United States
Acting Team Lead, Division of Therapeutic Performance, ORS, OGD, CDER
In Vitro Drug Release Testing of IUSs: Challenges to Solutions
Diane Burgess, PhD
University of Connecticut Department of Pharmaceutical Sciences , United States
Board of Trustees Distinguished Professor of Pharmaceutics
Development & In Vitro Release Testing of Intravaginal Rings
Bruce Frank, PhD
Lubrizol, United States
Vice President, Operations and Client Services
Panelist
Karyn L. Berry, MD, MPH
FDA, United States
Medical Officer, Division of Clinical Review, Office of Bioequivalence, OGD
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