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)

• 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

• IVRT Methods for In Situ Depot-Forming Long-Acting Injectable Products

  Mostofa, Agm

• Liposomes: Physicochemical Characterization and In Vitro Drug Release Testing

  Manna, Soumyarwit