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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Regulatory Uses of IVRT Studies on Complex Generic Ophthalmic, Injectable, Implantable, and Inserted Products
Qin, Bin
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Injectable Suspensions: Tools and Methods Bridging The In Vivo and In Vitro Gap
Qin, Bin
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Characterization and Comparative Evaluation Strategies to Demonstrate Complex Excipient Sameness
Qin, Bin
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Considerations for Establishing Q1/Q2 Sameness of Complex Formulations
Qin, Bin
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Demonstrating Equivalence of Generic Complex Drug Substances and Formulations: Advances in Characterization and In Vitro Testing
Park, Kinam
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Liposomes: Physicochemical Characterization and In Vitro Drug Release Testing
Manna, Soumyarwit
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Advanced Analytical Methods in Generic Drug Development and Approval
Kozak, Darby
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Demonstrating Complex Generic Product Equivalence: Benefits and Considerations When Using New Analytical Methods
Kozak, Darby
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Navigating Formulation Assessments: General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness
Kozak, Darby
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Generics for Long-Acting Injectables: Building a Pathway to Success
Lionberger, Robert