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 a Stable Single-vial Liposomal Formulation for Vincristine

  Mao, Wenxue; Wu, Fan; Lee, Robert; Lu, Weigen; Wang, Jianxin

• A Simple and Noninvasive DOSY NMR Method for Droplet Size Measurement of Intact Oil-In-Water Emulsion Drug Products

  Patil, Sharadrao; Li, Vincent; Peng, Jiangnan; Kozak, Darby; Xu, Jin; Cai, Bing; Keire, David; Chen, Kang

• From Q2 To Qbd: The Influence Of Formulation Changes On Mdi Performance

  Holt, Jay; Hickey, A; Sandell, D

• Snapshots of Iron Speciation: Tracking the Fate of Iron Nanoparticle Drugs via a Liquid Chromatography-Inductively Coupled Plasma- Mass Spectrometric Approach

  Neu, Heather; Alexishin, Sergei; Brandis, Joel; Williams, Anne; Li, Wenjing; Sun, Dajun; Zheng, Nan; Jiang, Wenlei; Zimrin, Ann; Fink, Jeffrey; Polli, James; Kane, Maureen; Michel, Sarah

• Coexistence of Oil Droplets and Lipid Vesicles in Propofol Drug Products

  Wu, Yong; Manna, Soumyarwit; Petrochenko, Peter; Koo, Bonhye; Chen, Lynn; Xu, Xiaoming; Choi, Stephanie; Kozak, Darby; Zheng, Jiwen

• Amphotericin B Release Rate is the Link between Drug Status in the Liposomal Bilayer and Toxicity

  Svirkin, Yuri; Lee, Jaeweon; Marx, Richard; Seongkyu, Yoon; Landrau, Nelson; Kaisar, Md Abul; Qin, Bin; Park, Jin H; Alam, Khondoker; Kozak, Darby; Wang, Yan; Xu, Xiaoming; Zheng, Jiwen; Rivnay, Benjamin

• Adaptive Perfusion: An In Vitro Release Test (IVRT) for Complex Drug Products

  Patel, Deval; Zhang, Ying; Dong, Yixuan; Qu, Haiou; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming

• In Vitro and In Vivo DFO-Chelatable Labile Iron Release Profiles among Commercially Available Intravenous Iron Nanoparticle Formulations

  Pai, Amy; Pai, Manjunath; Meyer, Dan; Bales, Brain; Cotero, Victoria; Zheng, Nan; Jiang, Wenlei

• Core Size Determination and Structural Characterization of Intravenous Iron Complexes by Cryogenic Transmission of Electron Microscopy

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

• Characterizing How Size Distribution and Concentration Affect Echogenicity of Ultrasound Contrast Agents

  Koo, Bonhye; Liu, Yunbo; Abboud, Monica; Qin, Bin; Wu, Yong; Choi, Stephanie; Kozak, Darby; Zheng, Jiwen