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(140)
• Posters(51)
• Presentations(34)
• Papers(55)

• Regulating Generic Nanotechnology Drug Products: Guidance and Standards

  Jiang, Wenlei

• Advanced Analytical Methods to Characterize Liposome Drug Products

  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

• 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