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(66)
• Posters(18)
• Presentations(27)
• Papers(21)

• The Impact of Product Quality Attributes on In Vivo Performance of Bupivacaine Multivesicular Liposomes

  Xia, Ziyun; Liu, Yayuan; Lu, Ziyi; Gan, Jingyao; Yu, Minzhi; Olsen, Karl; Wang, Yan; Xu, Xiaoming; Schwendeman, Steve; Schwendeman, Anna

• Utilization of AF4 for Characterizing Complex Nanomaterial Drug Products: Reexamining Sample Recovery and its Impact on Particle Size Distribution as a Quality Attribute

  Plavchak, Christine; Liu, Joanne; Wang, Yan; Xu, Xiaoming; Faustino, Patrick; Qu, Haiou; Smith, William C

• Mastering Particle Size Analysis: A Step-By-Step Illustration of Techniques and Best Practices

  Xu, Xiaoming

• Regulatory Perspectives: Method Validation and Common Deficiencies

  Smith, William

• Advanced Characterization of Injectafer®: Carboxymaltose Structure, Iron Core Structure, and Interaction of Carboxymaltose with Iron Core

  Shamim. Md Abdullah; Zhang, Tianyun; Huls, Nicholas; Munson, Eric J; Liu, Dahui; Chen, Kang; Qu, Haiou; Zhang, Li; Jiang, Wenlei; Wang, Yan; Zhang, Deyi

• Impact of Ionizable Lipid Source on the In Vitro Performance of siRNA Loaded Lipid Nanoparticles

  Ranjbar, Sheyda; Shih, Kuo-Chih; O’Reilly Beringhs, Andre; Qin, Bin; Wang, Yan; Lu, Xiuling

• Effect of Ionizable Lipid Source on the Quality Attributes of siRNA Lipid Nanoparticle Therapeutics

  Ranjbar, Sheyda; Shih, Kuo-Chih; O’Reilly Beringhs, Andre; Qin, Bin; Wang, Yan; Lu, Xiuling

• Manufacturing Process of Liposomal Formation: a Coarse-Grained Molecular Dynamics Simulation

  Duran, Tibo; Costa, Antonio P; Kneski, Jake; Xu, Xiaoming; Burgess, Diane J; Mohammadiarani, Hossein; Chaudhuri, Boshisattwa

• Intact NMR Approach Quickly Reveals Synchronized Microstructural Changes in Oil-in-Water Nanoemulsion Formulations

  Wang, Deyun; Li, Jiayi; Chen, Kang

• An Automated Capillary Electrophoresis Based Method for Drug Release Profiling of Liposomal Doxorubicin

  Jayaraj, Savithra; Jiang, Wenlei; Mudalige, Thilak