GDUFA Research Outcomes
Nanotechnology Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to generic products that contain nanomaterials or nanotechnology (e.g., colloidal iron-carbohydrate and liposomal products).
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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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Developing Discriminatory IVRT Methods for Injectable Suspensions: Start with Why
Smith, William C
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Thinking Outside the Box: Adaptive Perfusion Method to Study Drug Release from Emulsions
Xu, Xiaoming