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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Determining the Bio-distribution of Colloidal Iron Drug Products in Rats by Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
Beekman, Christopher; Matta, Murali; Mohammad, Adil; Gandhi, Adarsh; Sun, Dajun; Jiang, Wenlei; Lionberger, Robert; Rouse, Rodney; Patel, Vikram
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Impact of Manufacturing Process on Critical Quality Attributes of Multivesicular Liposomes
Bae, Jungeun; Patel, Mehulkumar; Manna, Soumyarwit; Smith, William; Vo, Anh; Wang, Yan; Choi, Stephanie; Kozak, Darby; Zheng, Jiwen; Xu, Xiaoming
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Scientific Considerations for Generic Cyclosporine Ophthalmic Emulsion In Vitro Bioequivalence Studies
Absar, Mohammad; Petrochenko, Peter; Choi, Stephanie