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.
-
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
-
Formulation Characterization of PLGA Microspheres
Schwendeman, Steven
-
A Cage Implant System for Assessing In Vivo Performance of Long Acting Release PLGA Depots
Schwendeman, Steven
-
Model-Integrated Methods and Innovative Study Designs for Generic LAI Product Development and Regulatory Assessment
Hooker, Andrew
-
Low Volume Dissolution Devices for Long Acting Periodontal Drug Products
Ren, Wei; Kelm, Gary; Choi, Stephanie; Kozak, Darby; Absar, Mohammad; Wang, Yan; Chow, Edwin; Walenga, Ross; Li, Kevin