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)

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

  Wang, Yan

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

  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

• Characterization of Complex Excipients and Formulations

  Wang, Yan

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

  Wang, Yan

• Challenges Associated with Development of Generic PLGAPLA Based Drug Products

  Wang, Yan

• Opportunities and Challenges for Modeling and Simulation in Development of Long-Acting Injectable Drug Products

  Sharan, Satish

• Application of Modeling and Simulation in Establishing Appropriate Bioequivalence Limits for Complex Formulations

  Sharan, Satish

• Evaluation Of Residual Levonorgestrel As Potential Bioequivalence Metric For A Long Acting Intrauterine System Using Quantitative Modeling And Simulation Approach

  Sharan, Satish