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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Correlation analysis of refractive index (dn/dc) for PLGAs with different ratios of lactide to glycolide,
Hadar, Justin; Garner, John; Skidmore, Sarah; Park, Haesun; Park, Kinam; Kozak, Darby; Wang, Yan
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Solvent-dependent PLGA Solubility for Separation of PLGAs with Different L:G Ratios
Hadar, Justin; Garner, John; Skidmore, Sarah; Park, Haesun; Park, Kinam; Kozak, Darby; Jiang, Xiaohui; Wang, Yan
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Toward Amorphous Indomethacin Ocular Suspensions And The Importance Of Preparation Methods On The Physical Stability
Fraser, Sara; Corvacho, Eduardo; Viitala, Tapani; Peltonen, Leena; Urtti, Arto; Strachan, Clare
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Understanding Drug Distribution and Release in Ophthalmic Emulsions
Dong, Yixuan; Hengst, Leanna; Hunt, Robert; Patel, Deval; Vo, Anh; Choi, Stephanie; Ashraf, Muhammad; Cruz, Celia; Xu, Xiaoming
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Understanding Bi-phasic Mass Transfer and Trans-membrane Diffusion Kinetics in Emulsions
Dong, Yixuan; Qu, Haiou; Hengst, Leanna; Choi, S; Absar, Mohammad; Li, Vincent; Zheng, Jiwen; Ashraf, Muhammad; Cruz, Celia; Xu, Xiaoming
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Bi-Phasic Mass Transfer and Trans-Membrane Diffusion in Emulsions
Dong, Yixuan; Qu, Haiou; Hengst, Leanna; Choi, Stephanie; Absar, Mohammad; Li, Vincent; Zheng, Jiwen; Ashraf, Muhammad; Cruz, Celia; Xu, Xiaoming
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Effect of Formulation and Process Variables on the Properties of Cyclosporine Ophthalmic Ointments
Dong, Yixuan; Qu, Haiou; Pavurala, Naresh; Wang, Jiang; Martinez, M; Fahmy, R; Ashraf, Muhammad; Cruz, Celia; Xu, Xiaoming
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Physicochemical Characterization Of Tobradex And Tobradex ST Under Physiological Conditions
Choi, Stephanie; Petrochenko, Peter; Wu, Yong; Kozak, Darby; Zheng, Jiwen
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Importance of Comparative Unit Dose Concentration in the Evaluation of Complex Ophthalmic Suspension Product Quality
Chen, Lynn; Manna, Soumyarwit; Petrochenko, Peter; Wu, Yong; Qin, Bin; Kozak, Darby; Zheng, Jiwen
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Effect of Particle Size and Viscosity of Ophthalmic Suspensions on Ocular Bioavailability
Bourne, David; Vooturi, Sunil; Panda, Jiban; Choi, Stephanie; Kim, Hyewon; Yandrapu, Sarath; Kompella, Uday