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Session 4 Part A: Ongoing Research in Long-Acting Generic Drug-Device Implant Products
Session Chair(s)
Darby Kozak, PhD
Lead for Complex Drug Substances and Dosage Forms, OGD, CDER
FDA, United States
Long-acting generic drug-device implantable products, such as intrauterine devices (IUDs), are complex products that can provide effective treatment for multiple years. These products are currently used by thousands of people in the United States. Although critical to public health, there are currently no approved generic IUD products due in part to the multifaceted considerations and associated challenges in their development. This is due in part to the complexity of IUD device design and materials used, in addition to the challenges associated designing an appropriate bioequivalence study for this type of product. This session will highlight the latest scientific research on physicochemical and bioequivalence testing for IUD products.
Speaker(s)
An Accelerated In Vitro Release Testing Method to Assess Q1/Q2 Formulated Levonorgestrel Intrauterine Devices
Diane Burgess, PhD
University of Connecticut Department of Pharmaceutical Sciences , United States
Board of Trustees Distinguished Professor of Pharmaceutics
Application of Modeling and Simulation in Establishing Appropriate Bioequivalence Limits for Long Acting Intrauterine Product
Satish Sharan
FDA, United States
Division of Quantitative Methods and Modeling, ORS, OGD, CDER
Research Related to Design and Composition Considerations in the Development of Generic Intrauterine Devices
Yan Wang, PhD
FDA, United States
Statistical Team Leader, Division of Biometrics IV, Office of Biostatistics, OTS