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.
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Determination of Globule Size Distribution of Cyclosporine Ophthalmic Emulsions using Asymmetric Flow Field Flow Fractionation
Qu, Haiou; Wang, Jiang; Wu, Yong; Zheng, Jiwen; Yellela, Krishnaiah; Absar, Mohammad; Choi, Stephanie; Ashraf, Muhammad; Cruz, Celia; Xu, Xiaoming
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Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Gatifloxacin Solution Case Study
Qaraghuli, Farah Al; Tan, Ming Liang; Walenga, Ross; Babiskin, Andrew; Zhao, Liang; Lukacova, Viera; Lemerdy, Maxime
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Physicochemical Characterization Of Tobradex And Tobradex ST Under Physiological Conditions
Petrochenko, Peter; Hu, Ping; Wu, Yong; Choi, Stephanie; Kozak, Darby; Zheng, Jiwen
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Impact of Process and Quality Control on the Physicochemical Properties of Tobramycin
Patere, Shilpa; Newman, Bryan; Choi, Stephanie; Wang, Yan; Jay, Michael; Lu, Xiuling
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Influence of Excipients on Physicochemical Characteristics of Ocular Semisolid Formulations and Their In Vitro Drug Release
Patere, Shilpa; Sutthanut, khaetthareeya; Newman, Bryan; Choi, Stephanie; Jay, Michael; Lu, Xiuling
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Preparation And Evaluation Of Difluprednate Topical Ocular Emulsions
Palakurthi, Srinath; Cai, Defu; Qiu, Jiang; Absar, Mohammad; Choi, Stephanie
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Membrane-Drug Binding and its Impact on In Vitro Release of Dexamethasone
Mekjaruskul, Catheleeya; Beringhs, Andre; Luo, Wei Chung; Xu, Qingguo; Halquist, Matthew; Qin, Bin; Wang, Yan; Lu, Xiuling
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Dexamethasone Degradation During In Vitro Release From An Intravitreal Implant
Matter, Brock; Ghaffari, Alireza; Bourne, David; Wang, Yan; Choi, Stephanie; Kompella, Uday
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Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Levofloxacin Solution Case Study
Le Merdy, Maxime; Zheng, Yujuan; Lukacova, Viera; Tan, Ming Liang; Babiskin, Andrew; Zhao, Liang
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Physiologically-based Pharmacokinetic Model to Support Ophthalmic Suspension Product Development
Le Merdy, Maxime; Fan, Jianghong; Babiskin, Andrew; Zhao, Liang