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(59)
• Posters(15)
• Presentations(25)
• Papers(19)

• High Resolution Chemical Imaging for Characterization of Intrauterine Systems and Nanomaterial Containing Drug Products

  Yilmaz, Huzeyfe

• Nanotechnology Meets Continuous Manufacturing: Learning from the Future

  Xu, Xiaoming

• Thinking Outside the Box: Adaptive Perfusion Method to Study Drug Release from Emulsions

  Xu, Xiaoming

• 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