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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Elevating Liposomal Formulation Analysis: An Advanced CE-C4D Method for Quantification of Ionic Excipients in Liposomal Doxorubicin
Jayaraj, Savithra; Jiang, Wenlei; Mudalige, Thilak
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Comprehensive Composition Analysis of Doxorubicin HCl Liposomes
Wijewantha, Nisitha; Gamage, Prabhath; Jiang, Wenlei; Mudalige, T
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Quantitative and Qualitative Analysis of Lipids and Cholesterol Derivatives in SMOF Lipids 20% Intravenous Lipid Emulsion
Gamage, Prabhath; Jiang, Wenlei; Mudalige, Thilak
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Doxorubicin HCl Release from Liposomal Doxorubicin Formulations Autonomous Capillary Electrophoretic (CE) In Vitro Release Test (IVRT) Method
Jayaraj, Savithra; Jiang, Wenlei; Mudalige, Thilak
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Qualitative and Quantitative Analysis of Lipids in Exparel� Injectable Liposomal Drug Formulation
Gamage, Prabhath; Jiang, Wenlei; Mudalige, Thilak
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Adaptive Perfusion: A Novel In Vitro Drug Release Testing Method for Complex Drug Products
Zhang, Ying; Patel, Deval; Zhu, Dongkai; Dong, Yixuan; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming
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Adaptive Perfusion: An In Vitro Drug Release Testing Method for Complex Drug Products
Zhang, Ying; Patel, Deval; Zhu, Dongkai; Dong, Yixuan; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming
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Adaptive Perfusion: An In Vitro Drug Release Testing Method for Complex Drug Products
Zhang, Ying; Patel, Deval; Zhu, Dongkai; Dong, Yixuan; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming
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Exploring an Electroanalytical Method to Determine Drug Release from Liposomal Doxorubicin HCl
Yurtsever, Fatma; Siriwardane, Dumindika; Jiang, Wenlei; Mudalige, Thilak
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Comparison Of Drug Release Profiles Of Doxorubicin Liposomes Prepared By Different Processes
Yuan, Wenmin; Kuai, Rui; Dai, Zhipeng; Tang, Jie; Zheng, Nan; Jiang, Wenlei; Noble, Charles; Hayes, Mark; Szoka, Francis; Schwendeman, Anna