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)

• 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

• Regulatory Uses of IVRT Studies on Complex Generic Ophthalmic, Injectable, Implantable, and Inserted Products

  Qin, Bin

• Injectable Suspensions: Tools and Methods Bridging The In Vivo and In Vitro Gap

  Qin, Bin

• Characterization and Comparative Evaluation Strategies to Demonstrate Complex Excipient Sameness

  Qin, Bin

• Considerations for Establishing Q1/Q2 Sameness of Complex Formulations

  Qin, Bin

• Demonstrating Equivalence of Generic Complex Drug Substances and Formulations: Advances in Characterization and In Vitro Testing

  Park, Kinam

• Liposomes: Physicochemical Characterization and In Vitro Drug Release Testing

  Manna, Soumyarwit