GDUFA Research Outcomes

Ophthalmic-Otic Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the ophthalmic or otic route, including solutions, suspensions and other dosage forms.

• All(147)
• Posters(63)
• Presentations(30)
• Papers(54)

• Application of Adaptive Perfusion as In Vitro Release Testing Method to Improve Understanding and Assessment of Complex Products

  Zhu, Dongkai

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

  Zhang, Feng

• Thinking Outside the Box: Adaptive Perfusion Method to Study Drug Release from Emulsions

  Xu, Xiaoming

• Regulatory Perspective on MMF Applications for OIDPs, Ophthalmic Drug Products, and Drug Products Applied on the Skin

  Walenga, Ross

• Bioequivalence Assessment for Complex Ophthalmic Products

  Urtti, Arto

• GDUFA Research Update on Mechanistic Modeling Approaches for Generic Ophthalmic, Nasal, Implant and Injectable Drug Products

  Tan, Mingliang

• Physiologically-based Pharmacokinetic Modeling to Support Generic Ophthalmic Product Development and Regulatory Decision Making

  Tan, Mingliang

• Developing Discriminatory IVRT Methods for Injectable Suspensions: Start with Why

  Smith, William C

• Intravitreal Sustained Release Ganciclovir: An Orphan Generic

  Smith, Thomas

• In vitro and in vivo characterization of ophthalmic suspensions

  Sailor, M