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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Probing the Mechanism of Bupivacaine Drug Release from Multivesicular Liposomes
Manna, Soumyarwit; Wu, Yong; Wang, Yan; Koo, Bonhye; Chen, Lynn; Petrochenko, Peter; Dong, Yixuan; Choi, Stephanie; Kozak, Darby; Oktem, Berk; Xu, Xiaoming; Zheng, Jiwen
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Distinguishing Pharmacokinetics of Marketed Nanomedicine Formulations Using a Stable Isotope Tracer Assay
Skoczen, Sarah; Snapp, Kelsie; Crist, Rachael; Kozak, Darby; Jiang, Xiaohui; Liu, Hao; Stern, Stephan
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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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Quantitative Analysis of Cholesterol Oxidation Products and Desmosterol in Parenteral Liposomal Pharmaceutical Formulations
Wang, Changguang; Siriwardane, Dumindika; Jiang, Wenlei; Mudalige, Thilak
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Comparative Evaluation of US Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Biodistribution after Intravenous Dosing in Rats
Beekman, Christopher; Matta, Murali; Thomas, Christopher; Mohammad, Adil; Stewart, Sharron; Xu, Lin; Chockalingam, Ashok; Shea, Katherine; Sun, Dajun; Jiang, Wenlei; Patel, Vikram; Rouse, Rodney