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(119)
• Posters(43)
• Presentations(31)
• Papers(45)

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

  Jiang, Wenlei

• Excipients in Parenteral Drug Products

  Jiang, Wenlei

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

  Hu, Meng

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

  Smith, William C

• 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

• Adaptive Perfusion: A Novel 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

• 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

• Exploring an Electroanalytical Method to Determine Drug Release from Liposomal Doxorubicin HCl

  Yurtsever, Fatma; Siriwardane, Dumindika; Jiang, Wenlei; Mudalige, Thilak