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)

• Exploring the Influence of Drug Substance Solid-State Properties on the In Vitro Drug Release Performance of Dexamethasone Ophthalmic Ointments

  O’Reilly Beringhs, Andre; Mekjaruskul, C; Qin, Bin; Wang, Yan; Lu, X

• Clinical Ocular Exposure Extrapolation for a Complex Ophthalmic Suspension Using Physiologically Based Pharmacokinetic Modeling and Simulation

  Le Merdy, M; Spires, J; Tan, M-L; Zhao, Liang; Lukacova, Viera

• Impact of Active Pharmaceutical Ingredient Variables and Oleaginous Base on the In Vitro Drug Release from Ophthalmic Ointments: an Investigation using Dexamethasone as a Model Drug

  Mekjaruskul, Catheleeya; O’Reilly Beringhs, Andre; Qin, Bin; Wang, Yan; Lu, Xiuling

• A New Analytical Method for Quantifying Acid-End-Cap PLGA inSub-Milligram Quantities

  Garner, John; Skidmore, Sarah; Overdorf, Gary; Hadar, Justin; Park, Haesun; Park, Kinam; Wang, Yan; Jhon, Young Kuk; Smith, William C; Zhang, Deyi; Zou, Yuan

• Analysis of Copolymerization with Simultaneous Reversibility and Transesterification by Stochastic Model Regression

  Kuehster, Louise; Dai, Jingyi; Thompson, Avery; Jhon, Young Kuk; Wang, Yan; Bin, Qin; Smith, William; Xu, Xiaoming; Zhang, Feng; Lynd, Nathaniel

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

  Costello, Mark; Liu, Joseph; Kuehster, Louise; Wang, Yan; Qin, Bin; Xu, Xiaoming; Li, Qi; Smith, William C; Lynd, Nathaniel A; Zhang, Feng

• Reverse Engineering the Ozurdex Dexamethasone Intravitreal Implant

  Costello, Mark; Liu, J; Wang, Yan; Bin, Qin; Xu, Xiaoming; Li, Qi; Lynd, Nathaniel A; Zhang, F

• Drug Release Mechanisms of High-Drug-Load, Melt-Extruded Dexamethasone Intravitreal Implants

  Costello, Mark; Liu, Joseph; Chen, Beibei; Wang, Yan; Qin, Bin; Xu, Xiaoming; Li, Qi; Lynd, Nathaniel A; Zhang, Feng

• Product Quality Research for Developing and Assessing Regulatory Submissions for Generic Cyclosporine Ophthalmic Emulsions

  Belenos, Avery; Wood, Erin; Hu, Meng; Kozak, Darby; Xu, Xiaoming; Fisher, Adam

• Clinical Ocular Exposure Extrapolation for Ophthalmic Solutions Using PBPK Modeling and Simulation

  Le Merdy, Maxime; Alqaraghuli, Farah; Tan, Ming Liang; Walenga, Ross; Babiskin, Andrew; Zhao, Liang; Lukacova, Viera