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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Generating Model-integrated Evidence for Developing and Approving Complex Generic LAI Products
Zhao, Liang
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Leveraging Modeling and Simulation to Make Regulatory Impacts for Long-Acting Generic Drug Approvals
Zhao, Liang
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Melt-Extruded Dexamethasone Ophthalmic Implants: Process, Structure and In Vitro Drug Release
Zhang, Feng
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Melt-Extruded Dexamethasone Ophthalmic Implants: Process, Structure and In Vitro Drug Release
Zhang, Feng
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Melt-extruded Dexamethasone Ophthalmic Implants-Process, Structure, and In Vitro Drug Release
Zhang, F
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Model-Integrated Bioequivalence Establishment: Long-Acting Injectable Drug Products
Yoon, Miyoung
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From Bench to Approval: the Role of GDUFA Research in Promoting Complex Generics
Wang, Yan
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Bioequivalence Approaches for Long-Acting Drug Products: Regulatory and Scientific Considerations
Wang, Yan
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Considerations and Expectations for in Vitro Release Testing of Complex Formulations
Wang, Yan
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Development of Generic Long Acting Injectables: Regulatory Challenges and Considerations
Wang, Yan