GDUFA Research Outcomes

Nanotechnology Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to generic products that contain nanomaterials or nanotechnology (e.g., colloidal iron-carbohydrate and liposomal products).

• All(66)
• Posters(18)
• Presentations(27)
• Papers(21)

• Scientific and Regulatory Considerations on In Vitro Release Testing (IVRT) and In Vitro In Vivo Correlation (IVIVC) for Complex Long-Acting Drug Suspensions

  Wang, Yan

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

  Tyner, Katherine

• Advanced Separations and Detection in Assessment of Quality for Drug Products Containing Nanomaterials

  Smith, William C

• Phytonadione ��� Self-Assembled System & Thermodynamics Systems

  Smith, William

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

  Smith, William C

• Amphotericin B Liposome: Revisions of the Product Specific Guidance

  Qin, Bin

• Nano-Size Complex Products IVRT

  Mudalige, Thilak

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

  Luke, Markham

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

  Kozak, Darby

• Development and Characterization of Generic Drug Products Containing Nanomaterials

  Kozak, Darby