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)

• Development of the Liposomal Amphotericin B Release Assay

  Tang, Jie; Yuan, Wenmin; Dai, Zhipeng; Li, Dan; Zheng, Nan; Jiang, Wenlei; Noble, Charles; Hayes, Mark; Szoka, Francis; Schwendeman, Anna

• Novel method to Determine Bioequivalence of Complex Drugs

  Stern, S T; Skoczen, S; Snapp, K S; Crist, R; Mcneil, S E

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

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

• Profiling In-Vitro Release of Verteporfin from VISUDYNE Liposomal Formulation and Investigating the Kinetics of Human Serum Albumin (HSA) – Verteporfin Complex Formation

  Siriwardane, Dumindika; Jiang, Wenlei; Mudalige, Thilak

• Continuous Monitoring of Albumin-Bound Paclitaxel Dissolution Profiles Using Dynamic Light Scattering and In Situ UV/Vis Fiber-Optic Probes

  Petrochenko, Peter; Wong, Sookyee; Wu, Yong; Zheng, Jiwen; Xu, Xiaoming; Choi, Stephanie; Kozak, Darby

• Scanning Electron Microscope (SEM) Coupled with Energy Dispersive X-ray Spectroscopy (EDS) – A Potential Analytical Tool for Physico-chemical Characterization of API in Complex Drug Formulations

  Patel, M; Manna, S; Vo, A; Xu, X; Conti, D; Choi, S; Kozak, D; Zheng, J

• 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

• 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

• Assessing High-Resolution Single Nanoparticle Counting Techniques to Improve the Regulatory Science of Complex Drug Products

  Myung, Ja-Hye; Zheng, Jiwen; Kozak, Darby

• Assessing High-Resolution Nanoparticle Counting Techniques for the Regulatory Science of Complex Drug Products

  Myung, Ja-Hye; Kozak, Darby; Zheng, Jiwen