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)

• Role of PLGA Variability in Controlled Drug Release from Dexamethasone Intravitreal Implants

  Zhang, Feng

• Melt-Extruded Dexamethasone Ophthalmic Implants: Process, Structure and In Vitro Drug Release

  Zhang, Feng

• Melt-Extruded Dexamethasone Ophthalmic Implants: Process, Structure and In Vitro Drug Release

  Zhang, Feng

• Melt-extruded Dexamethasone Ophthalmic Implants-Process, Structure, and In Vitro Drug Release

  Zhang, F

• Understanding Drug Release Mechanism in Long-acting Intrauterine Systems

  Zaman, R

• Model-Integrated Evidence for Bioequivalence Assessment of Long-Acting Injectables from a Generic Drug Perspective

  Yoon, Miyoung

• Model-Integrated Bioequivalence Establishment: Long-Acting Injectable Drug Products

  Yoon, Miyoung

• High Resolution Chemical Imaging for Characterization of Intrauterine Systems and Nanomaterial Containing Drug Products

  Yilmaz, Huzeyfe

• Role of GDUFA Research on Resolving Technical and Regulatory Challenges for Complex Generic Drug Development and Approval

  Wang, Yan

• The Journey of First Approvals of Complex Generic Long-acting Injectable Products

  Wang, Yan