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(148)
• Posters(54)
• Presentations(36)
• Papers(58)

• 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

• Characterizations of Nanomaterials

  Jiang,Wenlei

• Equivalence Testing of Complex Particle Size Distribution Profiles Based on Earth Mover’s Distance

  Hu, Meng

• Evaluation Of Biomarkers In Healthy Subjects Treated With Generic And Reference Sodium Ferric Gluconate

  Alloush, Jenna; Jones, Jace; Polli, James; Michel, Sarah; Kane, Maureen

• Mechanistic Modeling of Complex Injectables: Recommendations to Navigate Regulatory Challenges

  Andre, Kris

• 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