GDUFA Research Outcomes

Nanotechnology Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to generic products that contain nanomaterials or nanotechnology (e.g., colloidal iron-carbohydrate and liposomal products).

• All(28)
• Posters(6)
• Presentations(16)
• Papers(6)

• Developing Discriminatory IVRT Methods for Injectable Suspensions: Start with Why

  Smith, William C

• Thinking Outside the Box: Adaptive Perfusion Method to Study Drug Release from Emulsions

  Xu, Xiaoming

• Adaptive Perfusion: An In Vitro Drug Release Testing Method for Complex Drug Products

  Zhang, Ying; Patel, Deval; Zhu, Dongkai; Dong, Yixuan; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming

• Adaptive Perfusion: An In Vitro Drug Release Testing Method for Complex Drug Products

  Zhang, Ying; Patel, Deval; Zhu, Dongkai; Dong, Yixuan; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming

• Impact of Formulation Processes on Dosage Form Determination of Phytonadione Injectables

  Smith, William; Liu, Hao; Wang, Yan; Kozak, Darby; Xu, Xiaoming

• Interplay Between Particle Flocculation and Dissolution Leading to Variation in Bioavailability and Clinical Performance of Injectable Suspensions

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

• Characterization and Quantification Analysis of Onivyde Irinotecan Liposome Injection

  Gan, Jingyao; Juang, Vivian; Wang, Kaikai; Hong, Kristen; Xia, Ziyun; Ackermman, Rose; Olsen, Karl; Wang, Yan; Liang, Jing; Zheng, Jiwen; Xu, Xiaoming; Park, Jin; Schwendeman, Anna

• Effect of Manufacturing Process on Particle Morphology in Propofol Emulsions

  Feng, Wenchun; Wu, Yong; Chen, Lynn; Qu, Haiou; Patel, Deval; Xu, Xiaoming; Manna, Soumyarwit; Choi, Stephanie; Zheng, Jiwen