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(162)
• Posters(65)
• Presentations(34)
• Papers(63)

• Impact of FDA Regulatory Research on the Landscape of Ophthalmology Drugs

  O’Reilly Beringhs, Andre

• Ocular PBPK/PD Modeling to Explore In Vitro Bioequivalence Approach for Brinzolamide Ophthalmic Suspensions

  Tan, Mingliang

• Navigating Formulation Assessment: Considerations When Preparing the Q1/Q2 Sameness Inquiry

  Zhang, Qiangnan

• Predicting Brinzolamide Ocular Response in Humans Using an Ocular PBPK-PD Modeling and Simulation

  Le Merdy, Maxime; Mullin, Jim; Tan, Ming-Liang; Lukacova, Viera

• Microstructural and Compositional Analysis of Dexamethasone-Loaded Poly(Lactide-Co-Glycolide) Rods

  Garner, J; Hadar, Justin; Skidmore, S; Park, H; Park, K; Wang, Y; Jhou, Y; Smith, W; Zhang, D; Zou, Y

• 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

• 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

• 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