GDUFA Research Outcomes
LAI Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to long-acting injectable, insertable or implantable (collectively, LAI) generic products.
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Developing Discriminatory IVRT Methods for Injectable Suspensions: Start with Why
Smith, William C
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Advanced Imaging and Data Analysis to Support Structure Similarity of Polymeric Formulations
Wang, Yan
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Application of Quantitative Modeling and Simulations to Bioequivalence Determination for Long-Acting Injectables – Sharing Research Progress and Regulatory Experience
Feng, Kairui
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Bioequivalence of Intravaginal Rings and Intrauterine Systems: Current Perspective and Future Directions
Wang, Yan
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Bioequivalence of Polymeric Long Acting Drugs
Wang, Yan
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Model-informed Drug Development for Long-acting Injectable Products
Fang, Lanyan (Lucy)
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Model-Integrated Evidence for Bioequivalence Assessment of Long-Acting Injectables from a Generic Drug Perspective
Yoon, Miyoung
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Generic Drug Regulatory Research: In Vitro Equivalence Testing
Choi, Stephanie
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IVRT Method Development for API Suspension Products and Validation with In Vivo Models
Burgess, Diane J
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In Vitro Drug Release from Complex Parenterals and Development of IVIVCs
Burgess, D