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)

• 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

• Liposomal Doxorubicin Under Microconfinement and Microscopy

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

• Considerations for Post-Approval Changes to Complex Generic Drug Products

  Kozak, Darby

• Development and Characterization of Generic Drug Products Containing Nanomaterials

  Kozak, Darby

• A Scientific and Regulatory Overview of IVRT: Current Considerations and Challenges

  Kozak, Darby

• Characterizations of Nanomaterials

  Jiang,Wenlei

• Complex Generics Containing Nanomaterials: Developments in 2021 and 2022

  Jiang, Wenlei

• Regulating Generic Nanotechnology Drug Products: Guidance and Standards

  Jiang, Wenlei

• Regulatory Research in Nanomedicine Drug Products

  Jiang, Wenlei