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(300)
• Posters(133)
• Presentations(76)
• Papers(91)

• Developing Discriminatory IVRT Methods for Injectable Suspensions: Start with Why

  Smith, William C

• In Vitro Release Testing Of Complex Parenteral Dosage Forms

  Shen, Jie

• Model-Informed and Model-Integrated Approaches in BE Assessment of Long Acting Injectable Products

  Sharan, Satish

• 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

• Exenatide PLGA Microspheres

  Schwendeman, S

• Formulation Characterization of PLGA Microspheres

  Schwendeman, Steven

• A Cage Implant System for Assessing In Vivo Performance of Long Acting Release PLGA Depots

  Schwendeman, Steven

• 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