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)

• 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

• Advances in Iron Colloid Products: Product-Specific Guidance Discussion

  Jiang, Wenlei

• Complex Drug Products Containing Nanomaterials

  Jiang, Wenlei

• 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

• 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