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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A Scientific and Regulatory Overview of IVRT: Current Considerations and Challenges
Kozak, Darby
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Characterizations of Nanomaterials
Jiang,Wenlei
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Complex Generics Containing Nanomaterials: Developments in 2021 and 2022
Jiang, Wenlei
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Regulating Generic Nanotechnology Drug Products: Guidance and Standards
Jiang, Wenlei
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Regulatory Research in Nanomedicine Drug Products
Jiang, Wenlei
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US FDA Perspectives for Bioequivalence (BE) Evaluation of Liposome Drug Products
Jiang, Wenlei
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Excipients in Parenteral Drug Products
Jiang, Wenlei
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Equivalence Testing of Complex Particle Size Distribution Profiles Based on Earth Mover’s Distance
Hu, Meng
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Developing Discriminatory IVRT Methods for Injectable Suspensions: Start with Why
Smith, William C
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Evaluation Of Biomarkers In Healthy Subjects Treated With Generic And Reference Sodium Ferric Gluconate
Alloush, Jenna; Jones, Jace; Polli, James; Michel, Sarah; Kane, Maureen