GDUFA Research Outcomes
Injectable Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to injectable generic drug products.
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Assessing Particle Counting Techniques to Improve the Regulatory Review of Complex Colloidal Drug Products
Myung, Ja Hye
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Significance of Cryo-scanning Electron Microscopy (cryo-SEM) in Evaluating the Morphology of Multivesicular Liposomes
Manna, Soumyarwit
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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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Navigating Formulation Assessments: General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness
Kozak, Darby
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Biomaterials as Pertains to Drug Products, including Generic Drug Products with Biomaterial Components
Luke, Markham
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Scattering from Microbubble Clouds: A Fast Multipole Model with Experimental Validation
Liu, Yunbo
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Liposomal Doxorubicin Under Microconfinement and Microscopy
Liao, K; Copeland, C; Myung, J; Kozak, Darby; Stavis, S
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Considerations for Post-Approval Changes to Complex Generic Drug Products
Kozak, Darby
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Development and Characterization of Generic Drug Products Containing Nanomaterials
Kozak, Darby