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)

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

  Qin, Bin

• Non-Inferiority Assessment for Iron-Carbohydrate Complexes

  Polli, James E.

• 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

• Biomaterials as Pertains to Drug Products, including Generic Drug Products with Biomaterial Components

  Luke, Markham

• Scattering from Microbubble Clouds: A Fast Multipole Model with Experimental Validation

  Liu, Yunbo

• Scientific Challenges in the Development of Complex Injectables

  Lionberger, R

• Liposomal Doxorubicin Under Microconfinement and Microscopy

  Liao, K; Copeland, C; Myung, J; Kozak, Darby; Stavis, S