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)

• NIPTE Workshop 2024: Injectables with Complex Formulations and Assessment

  Wang, Yan

• Regulatory Research Supporting the Development of Drug Products Containing Nanomaterials A US-FDA Perspective

  Tyner, Katherine

• Nanomedicine Pharmacokinetics and Bioanalytical Methods to Measure Drug Release

  Stern, Stephan

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

  Smith, William C

• Regulatory Uses of IVRT Studies on Complex Generic Ophthalmic, Injectable, Implantable, and Inserted Products

  Qin, Bin

• 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