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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Bioanalytical Approaches To Measure Iron Speciation In The Plasma Of Patients Treated With Iron-Nanoparticle Drug Products
Neu, Heather; Smith, Aaron; Wilks, Angela; Polli, James; Kane, Maureen; Ting, Tricia; Michel, Sarah
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Comprehensive Physico-chemical Characterization of Liposomal Doxorubicin
Naik, Satish Jayavant; Palui, Goutam; Majumdar, Sanghamitra; Raghavendra, Achyut; Sharmah, Arjun; Koonce, Nathan; Zheng, Jiwen; Paredes, Angel; Jiang, Wenlei; Patri, Anil
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Assessing High-Resolution Single Nanoparticle Counting Techniques to Improve the Regulatory Science of Complex Drug Products
Myung, Ja-Hye; Zheng, Jiwen; Kozak, Darby
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Assessing High-Resolution Nanoparticle Counting Techniques for the Regulatory Science of Complex Drug Products
Myung, Ja-Hye; Kozak, Darby; Zheng, Jiwen
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New Tools to Improve Complex Drug Regulation: Establishing Simple and Cost-efficient Techniques for nanoparticle Counting
Myung, Ja-Hye; Elliott, Lindsay; Stavis, Samuel; Zheng, Jiwen; Kozak, Darby
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Cellular Pharmacokinetic/Pharmacodynamic Of Doxorubicin In A Wide Array Of Cell Lines.
LeMerdy, Maxime; Hendriks, Bart; Cao, Yanguang
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Quantification of Drug Bound Iron, non-Transferrin Bound Iron, Transferrin Bound Iron, and Total Iron in Serum in a Rat Pharmacokinetic Study
Matta, Murali; Beekman, Christopher; Gandhi, Adarsh; Rouse, Rodney
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Mechanistic Understanding of In Vitro Drug Release of Bupivacaine from Multivesicular Liposomes
Manna, Soumyarwit; Petrochenko, Peter; Wu, Yong; Koo, Bonhye; Chen, Lynn; Dong, Yixuan; Xu, Xiaoming; Choi, Stephanie; Kozak, Darby; Wang, Yan; Zheng, Jiwen
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Developing Physicochemical Characterization and In vitro Release Test Methods to Probe Drug Release Mechanism from Multivesicular Liposomes
Manna, Soumyarwit; Wu, Yong; Petrochenko, Peter; Koo, Bonhye; Chen, Lynn; Dong, Yixuan; Xu, Xiaoming; Choi, Stephanie; Kozak, Darby; Wang, Yan; Zheng, Jiwen
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Probing Mechanism of Drug Release from Multivesicular Liposomes
Manna, Soumyarwit; Wu, Yong; Petrochenko, Peter; Koo, Bonhye; Chen, Lynn; Dong, Yixuan; Xu, Xiaoming; Choi, Stephanie; Kozak, Darby; Wang, Yan; Zheng, Jiwen