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(202)
• Posters(97)
• Presentations(51)
• Papers(54)

• Advanced Analytical Methods in Generic Drug Development and Approval

  Kozak, Darby

• Demonstrating Complex Generic Product Equivalence: Benefits and Considerations When Using New Analytical Methods

  Kozak, Darby

• Navigating Formulation Assessments: General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness

  Kozak, Darby

• Generics for Long-Acting Injectables: Building a Pathway to Success

  Lionberger, Robert

• Stochastic and Deterministic Analysis of Reactivity Ratios in the Partially Reversible Copolymerization of Lactide and Glycolide

  Kuehster, Louise

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

  Kozak, Darby

• Development of Model-Informed Bioequivalence Evaluation Strategies for Long-Acting Injectable Products (LAI)

  Karlsson, Matt; Chen, Xiaomei; Hooker, Andrew

• An Overview of Challenges and Opportunities for Innovation in Complex Generic Drug Product Development

  Jiang, Xiaohui

• Current Thinking and Research On In Vitro Only Approaches for Injectable Drug Substance Suspensions-A Scientific Discussion

  Qin, Bin

• Bioequivalence of Long Acting Injectable (LAI) Suspensions: Current Perspective and Future Directions

  Qin, Bin