GDUFA Research Outcomes
LAI Products
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The Journey of First Approvals of Complex Generic Long-acting Injectable Products
Wang, Yan
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Regulatory and Scientific Considerations For Demonstrating Pharmaceutical Equivalence and Bioequivalence of Poly (lactide-co-glycolide) Based Long-Acting Injectable Products
Wang, Yan
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From Bench to Approval: the Role of GDUFA Research in Promoting Complex Generics
Wang, Yan
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Advanced Imaging and Data Analysis to Support Structure Similarity of Polymeric Formulations
Wang, Yan
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Bioequivalence of Intravaginal Rings and Intrauterine Systems: Current Perspective and Future Directions
Wang, Yan
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Bioequivalence Approaches for Long-Acting Drug Products: Regulatory and Scientific Considerations
Wang, Yan
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Bioequivalence of Polymeric Long Acting Drugs
Wang, Yan
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Development of Generic Long Acting Injectables: Regulatory Challenges and Considerations
Wang, Yan
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Considerations and Expectations for in Vitro Release Testing of Complex Formulations
Wang, Yan
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Characterization of Complex Excipients and Formulations
Wang, Yan