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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Characterization of the Globule Size Distribution of Cyclosporine Ophthalmic Emulsion by Cryogenic Electron Microscopy
Wu, Yong; Petrochenko, Peter; Absar, Mohammad; Wong, Sook Yee; Choi, Stephanie; Zheng, Jiwen
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A Critical Evaluation of Emerging High Resolution Imaging Technologies for the Characterization of Complex Formulations
Tyner, Katherine
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Development of Flow-through USP 4 Apparatus Release Assay for Doxorubicin Liposome
Wenmin, Yuan; Kuai, Rui; Dai, Zhipeng; Yuan, Yue; Zheng, Nan; Jiang, Wenlei; Noble, Charles; Hayes, Mark; Schwendeman, Anna
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Development of the Liposomal Amphotericin B Release
Tang, Jie; Acevedo, Frances; Yuan, Wenmin; Dai, Zhipeng; Li, Dan; Zheng, Nan; Jiang, Wenlei; Noble, Charles; Hayes, Mark; Szoka, Francis; Schwendeman, Anna
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Development of the Liposomal Amphotericin B Release Assay
Tang, Jie; Yuan, Wenmin; Dai, Zhipeng; Li, Dan; Zheng, Nan; Jiang, Wenlei; Noble, Charles; Hayes, Mark; Szoka, Francis; Schwendeman, Anna
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Novel method to Determine Bioequivalence of Complex Drugs
Stern, S T; Skoczen, S; Snapp, K S; Crist, R; Mcneil, S E
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Impact of Particle Flocculation on Dissolution and Implications on Bioavailability of Injectable Suspensions
Smith, William; Bae, Jungeun; Zhang, Ying; Wang, Yan; Qin, Bin; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming
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Profiling In-Vitro Release of Verteporfin from VISUDYNE Liposomal Formulation and Investigating the Kinetics of Human Serum Albumin (HSA) – Verteporfin Complex Formation
Siriwardane, Dumindika; Jiang, Wenlei; Mudalige, Thilak
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Continuous Monitoring of Albumin-Bound Paclitaxel Dissolution Profiles Using Dynamic Light Scattering and In Situ UV/Vis Fiber-Optic Probes
Petrochenko, Peter; Wong, Sookyee; Wu, Yong; Zheng, Jiwen; Xu, Xiaoming; Choi, Stephanie; Kozak, Darby
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Scanning Electron Microscope (SEM) Coupled with Energy Dispersive X-ray Spectroscopy (EDS) – A Potential Analytical Tool for Physico-chemical Characterization of API in Complex Drug Formulations
Patel, M; Manna, S; Vo, A; Xu, X; Conti, D; Choi, S; Kozak, D; Zheng, J