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)

• Challenges Associated with Development of Generic PLGAPLA Based Drug Products

  Wang, Yan

• Regulatory Considerations in Development of Generic LAI Formulations for HIV Treatment and Prevention

  Struble, Kimberly

• 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

• Formulation Characterization of PLGA Microspheres

  Schwendeman, Steven

• Exenatide PLGA Microspheres

  Schwendeman, S