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)

• Comparison Of Drug Release Profiles Of Doxorubicin Liposomes Prepared By Different Processes

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

• Development of Flow-through USP 4 Apparatus Release Assay to Evaluate Doxorubicin Liposomes

  Yuan, Wenmin; Kuai, Rui; Dai, Zhipeng; Yuan, Yue; Zheng, Nan; Jiang, Wenlei; Noble, Charles; Hayes, Mark; Szoka, Francis; Schwendeman, Anna

• Distinguish Coexistence of Nanoemulsion and Liposome in Propofol by Cryogenic Transmission Electron Microscopy

  Wu, Yong; Petrochenko, Peter; Koo, Bonhye; Manna, Soumyarwit; Myung, Ja Hye; Hye; Choi, Stephanie; Kozak, Darby; Zheng, Jiwen

• Evaluating Complex Emulsion and Liposome Morphology in Propofol Drug Products with High Resolution Cryogenic Electron Microscopy

  Wu, Yong; Petrochenko, Peter; Liu, Jikun; Manna, Soumyarwit; Koo, Bonhye; Myung, Ja Hye; Chen, Lynn; Choi, Stephanie; Kozak, Darby; Zheng, Jiwen

• Distinguish Coexistence of Nanoemulsion and Liposome in Propofol by Cryogenic Transmission Electron Microscopy

  Wu, Yong; Petrochenko, Peter; Koo, Bonhye; Manna, Soumyarwit; Myung, Ja Hye; Choi, Stephanie; Kozak, Darby; Zheng, Jiwen

• Comparative In Vitro Cellular Uptake Study on Reference and Generic Sodium Ferric Gluconate in Mononuclear Phagocyte Systems

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

• Characterization of the Globule Size Distribution of Cyclosporine Ophthalmic Emulsion by Cryogenic Electron Microscopy

  Wu, Yong; Petrochenko, Peter; Absar, Mohammad; Wong, Sook Yee; Choi, Stephanie; Zheng, Jiwen

• A Critical Evaluation of Emerging High Resolution Imaging Technologies for the Characterization of Complex Formulations

  Tyner, Katherine

• Development of Flow-through USP 4 Apparatus Release Assay for Doxorubicin Liposome

  Wenmin, Yuan; Kuai, Rui; Dai, Zhipeng; Yuan, Yue; Zheng, Nan; Jiang, Wenlei; Noble, Charles; Hayes, Mark; Schwendeman, Anna

• Development of the Liposomal Amphotericin B Release

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