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)

• 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

• Long-Acting Injectables: Advances in In Vitro Equivalence Testing

  Qin, Bin

• Current Thinking and Research On In Vitro Only Approaches for Injectable Drug Substance Suspensions-A Scientific Discussion

  Qin, Bin

• 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

• Bioequivalence of Long Acting Injectable (LAI) Suspensions: Current Perspective and Future Directions

  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

• Analysis of PLGAs in Complex Long-Acting Injectable Formulations

  Park, K