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(59)
• Posters(15)
• Presentations(25)
• Papers(19)

• Regulating Generic Nanotechnology Drug Products: Guidance and Standards

  Jiang, Wenlei

• Regulatory Research in Nanomedicine Drug Products

  Jiang, Wenlei

• US FDA Perspectives for Bioequivalence (BE) Evaluation of Liposome Drug Products

  Jiang, Wenlei

• Excipients in Parenteral Drug Products

  Jiang, Wenlei

• Doxorubicin HCl Release from Liposomal Doxorubicin Formulations – Autonomous Capillary Electrophoretic (CE) In Vitro Release Test (IVRT) Method

  Jayaraj, Savithra; Jiang, Wenlei; Mudalige, Thilak

• Characterization of Intravenous Iron Supplements: Injectafer

  Zhang, Tianyun; Shamim, Md Abdullah; Tower, Cole; Sapkota, Rachana; Munson, Eric J; Liu, Dahui; Chen, Kang; Jiang, Wenlei; Wang, Yan; Zhang, Deyi

• Qualitative and Quantitative Analysis of Lipids in Exparel® Injectable Liposomal Drug Formulation

  Gamage, Prabhath; Jiang, Wenlei; Mudalige, Thilak

• Elevating Liposomal Formulation Analysis: An Advanced CE-C4D Method for Quantification of Ionic Excipients in Liposomal Doxorubicin

  Jayaraj, Savithra; Jiang, Wenlei; Mudalige, Thilak

• Comprehensive Composition Analysis of Doxorubicin HCl Liposomes

  Wijewantha, Nisitha; Gamage, Prabhath; Jiang, Wenlei; Mudalige, T

• Effect of Process Parameters and Buffer Exchange on the Critical Quality Attributes of siRNA Loaded Lipid Nanoparticles

  Ranjbar, Sheyda; O’Reilly Beringhs, Andre; Bin, Qin; Wang, Yan; Lu, Xiuling