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)

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

  Mostofa, Agm

• Liposomes: Physicochemical Characterization and In Vitro Drug Release Testing

  Manna, Soumyarwit

• Understanding and Characterizing the Sequence Blockiness of Poly(lactide-co-glycolide)

  Lynd, AN

• Imaging In Situ Forming Implants for Advanced Characterization

  Lu, Xiuling

• Novel In Vitro, Ex Vivo and In Vivo Assessment of Ophthalmic Semi-Solid Drug Products

  Lu, Xiuling

• Generics for Long-Acting Injectables: Building a Pathway to Success

  Lionberger, Robert

• PBPK Models of Complex Injectable and Ophthalmic Drug Products: Case Studies

  Le Merdy, Maxime

• Stochastic and Deterministic Analysis of Reactivity Ratios in the Partially Reversible Copolymerization of Lactide and Glycolide

  Kuehster, Louise

• A Scientific and Regulatory Overview of IVRT: Current Considerations and Challenges

  Kozak, Darby

• Advanced Analytical Methods in Generic Drug Development and Approval

  Kozak, Darby