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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Multiphase Drug Distribution and Exchange in Oil-in-Water Nanoemulsion Revealed by High-Resolution 19F qNMR
Wang, Deyun; Park, Jin H; Zheng, Jiwen; Cai, Bing; Keire, David; Chen, Kang
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Adaptive Perfusion: An In Vitro Release Test (IVRT) for Complex Drug Products
Patel, Deval; Zhang, Ying; Dong, Yixuan; Qu, Haiou; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming
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Injectable, Long-Acting PLGA Formulations: Analyzing PLGA and Understanding Microparticle Formation
Park, Kinam; Skidmore, Sarah; Hadar, Justin; Garner, John; Park, Haesun; Otte, Andrew; Soh, Bong Kwan; Yoon, Gwangheum; Yu, Dijia; Yun, Yeonhee; Lee, Byung Kook; Jiang, Xiaohui; Wang, Yan
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Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: BDrug Products, Including Biological Products, that Contain Nanomaterials
Vlieger, Jon; Crommelin, Daan; Tyner, Katherine; Drummond, Daryl; Jiang, Wenlei; Mcneil, Scott; Neervannan, Sesha; Crist, Rachael; Shah, Vinod
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Impact of Particle Flocculation on the Dissolution and Bioavailability of Injectable Suspensions
Smith, William; Bae, Jungeun; Zhang, Ying; Qin, Bin; Wang, Yan; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming
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Scientific and Regulatory Considerations for Generic Complex Drug Products Containing Nanomaterials
Zheng, Nan; Sun, Dajun; Zou, Peng; Jiang, Wenlei
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Regulatory Research Supporting the Development of Drug Products Containing Nanomaterials A US-FDA Perspective
Tyner, Katherine
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Complex Drug Products Containing Nanomaterials
Jiang, Wenlei
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Liposome Guidance
Jiang, Wenlei
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Demonstrating Complex Generic Product Equivalence: Benefits and Considerations When Using New Analytical Methods
Kozak, Darby