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)

• Injectable Suspensions: Tools and Methods Bridging The In Vivo and In Vitro Gap

  Qin, Bin

• Liposome Guidance

  Jiang, Wenlei

• Non-Inferiority Assessment for Iron-Carbohydrate Complexes

  Polli, James E.

• Advanced Analytical Methods to Characterize Liposome Drug Products

  Jiang, Wenlei

• Liposomal Formulations of Amphotericin B

  Nivorozhkin, Alex; Rivnay, Benjamin

• Assessing Particle Counting Techniques to Improve the Regulatory Review of Complex Colloidal Drug Products

  Myung, Ja Hye

• Significance of Cryo-scanning Electron Microscopy (cryo-SEM) in Evaluating the Morphology of Multivesicular Liposomes

  Manna, Soumyarwit

• Liposomes: Physicochemical Characterization and In Vitro Drug Release Testing

  Manna, Soumyarwit

• Advanced Analytical Methods in Generic Drug Development and Approval

  Kozak, Darby

• Navigating Formulation Assessments: General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness

  Kozak, Darby