GDUFA Research Outcomes

Injectable Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to injectable generic drug products.

• All(119)
• Posters(43)
• Presentations(31)
• Papers(45)

• Comparative Evaluation of US Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: in Vitro Cellular Uptake

  Wu, Min; Sun, Dajun; Tyner, Katherine; Jiang, Wenlei; Rouse, Rodney

• Probing the Mechanism of Drug Release from Liposomes

  Park, Kinam

• Quantification of Phospholipid Degradation Products in Liposomal Pharmaceutical formulations by Ultra Performance Liquid Chromatography-Mass Spectrometry (UPLC-MS)

  Siriwardane, Dumindika; Wang, Changguang; Jiang, Wenlei; Mudalige, Thilak

• Impact of Particle Flocculation on the Dissolution and Bioavailability of Injectable Suspensions

  Smith, William; Bae, Jungeun; Zhang, Ying; Qin, Bin; Wang, Yan; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming

• Optimization of the manufacturing process of a complex amphotericin B liposomal formulation using quality by design approach

  Liu, Huolong; Rivnay, Benjamin; Avery, Ken; Myung, Ja Hye; Kozak, Darby; Landrau, Nelson; Nivorozhkin, Alex; Ashraf, Muhammad; Yoon, Seongkyu

• Equivalence Testing of Complex Particle Size Distribution Profiles Based on Earth Mover’s Distance

  Hu, Meng; Jiang, Xiaohui; Absar, Mohammad; Choi, Stephanie; Kozak, Darby; Shen, Meiyu; Weng, Yuting; Zhao, Liang; Lionberger, Robert

• Critical Process Parameters in Manufacturing of Liposomal Formulations of Amphotericin B

  Rivnay, Benjamin; Wakim, Joseph; Avery, Ken; Petrochenko, Peter; Myung, Ja Hye; Kozak, Darby; Yoon, Seongkyu; Landrau, Nelson; Nivorozhkin, Alex

• Direct Quantification of Unencapsulated Doxorubicin in Liposomal Doxorubicin Formulations Using Capillary Electrophoresis

  Ansar, Siyam; Jiang, Wenlei; Mudalige, Thilak

• Analysis of Phospholipids and Triacylglycerols in Intravenous Lipid Emulsions

  Banstola, Bijay; Gamage, Prabhath; Jiang, Wenlei; Mudalige, Thilak

• Metabolism of Bupropion by Carbonyl Reductases in Liver and Intestine

  Connarn, Jamie; Zhang, Xinyuan; Babiskin, Andrew; Sun, Duxin