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(272)
• Posters(124)
• Presentations(72)
• Papers(76)

• 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

• Demonstrating Equivalence of Generic Complex Drug Substances and Formulations: Advances in Characterization and In Vitro Testing

  Park, Kinam

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

  Karlsson, Matt; Chen, Xiaomei; Hooker, Andrew

• Bioequivalence Assessment for Long-Acting Injectables (LAIs) – FDA Regulatory Perspectives

  Jiang, Wenlei

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

  Jiang, Xiaohui

• Model-Integrated Methods and Innovative Study Designs for Generic LAI Product Development and Regulatory Assessment

  Hooker, Andrew

• Correlating The In Vitro Dissolution Behavior Of Inhalation And Nasal Drug Products With In Vivo Performance: Pitfalls And Potential Solutions Using The Transwell System

  Hochhaus, Guenther

• Application of Quantitative Modeling and Simulations to Bioequivalence Determination for Long-Acting Injectables – Sharing Research Progress and Regulatory Experience

  Feng, Kairui

• Enabling the Rational Development of Long-Acting Contraceptive Levonorgestrel Intrauterine Systems

  Fanse, Suraj