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)

• Regulatory and Scientific Considerations For Demonstrating Pharmaceutical Equivalence and Bioequivalence of Poly (lactide-co-glycolide) Based Long-Acting Injectable Products

  Wang, Yan

• From Bench to Approval: the Role of GDUFA Research in Promoting Complex Generics

  Wang, Yan

• Advanced Imaging and Data Analysis to Support Structure Similarity of Polymeric Formulations

  Wang, Yan

• Bioequivalence of Intravaginal Rings and Intrauterine Systems: Current Perspective and Future Directions

  Wang, Yan

• Bioequivalence Approaches for Long-Acting Drug Products: Regulatory and Scientific Considerations

  Wang, Yan

• Bioequivalence of Polymeric Long Acting Drugs

  Wang, Yan

• Considerations and Expectations for in Vitro Release Testing of Complex Formulations

  Wang, Yan

• Development of Generic Long Acting Injectables: Regulatory Challenges and Considerations

  Wang, Yan

• Long Acting Injectable and Implantable Drug Product Development Regulatory Challenges and Considerations_GSK-CRS Conference

  Wang, Yan

• Characterization of Complex Excipients and Formulations

  Wang, Yan