GDUFA Research Outcomes

LAI Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to long-acting injectable, insertable or implantable (collectively, LAI) generic products.

• All(300)
• Posters(133)
• Presentations(76)
• Papers(91)

• Predicting Drug Release from Long-Acting Implants: Mechanisms, Modeling, and Simulation

  Zhong, Ziyue

• Compositional Sameness for Complex Polymeric Excipients: Progress and Remaining Challenges

  Qin, Bin

• Considerations of Bioequivalence Studies for Long-Acting Injectables and the Application of Model-Integrated Evidence Approaches

  Gong, Yuqing

• Navigating Formulation Assessment: Considerations When Preparing the Q1/Q2 Sameness Inquiry

  Zhang, Qiangnan

• Generating Model-integrated Evidence for Developing and Approving Complex Generic LAI Products

  Zhao, Liang

• Leveraging Modeling and Simulation to Make Regulatory Impacts for Long-Acting Generic Drug Approvals

  Zhao, Liang

• Generating Model-integrated Evidence for Developing & Approving Complex Generic LAI Products.

  Zhao, L

• Image-Based Porosity, Density, and In Silico Modeling for Product Equivalence Assessment

  Zhang, Shawn

• Role of PLGA Variability in Controlled Drug Release from Dexamethasone Intravitreal Implants

  Zhang, Feng

• Melt-Extruded Dexamethasone Ophthalmic Implants: Process, Structure and In Vitro Drug Release

  Zhang, Feng