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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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
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In Vitro – Ex Vivo Correlation of Drug Release from Semisolid Ophthalmic Ointments
Bao, Quanying; Newman, Bryan; Wang, Yan; Choi, Stephanie; Burgess, Diane
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Impact of Excipient Sources on In Vitro Drug Release Characteristics of Semisolid Ophthalmic Ointments
Bao, Quanying; Shen, Jie; Newman, Bryan; Wang, Yan; Choi, Stephanie; Burgess, Diane
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Manufacturing Differences on Physicochemical and In Vitro Release Characteristics of Semisolid Ophthalmic Ointments
Bao, Quanying; Shen, Jie; Newman, Bryan; Wang, Yan; Choi, Stephanie; Burgess, Diane
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Impact of Excipient Sources on In Vitro Drug Release Characteristics of Semisolid Ophthalmic Ointments
Bao, Quanying; Shen, Jie; Newman, Bryan; Wang, Yan; Choi, Stephanie; Burgess, Diane
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Sustained Release Dexamethasone Implants For In-Vitro Vivo Correlations
Bai, Yunpeng; Bourne, David; Wang, Yan; Choi, Stephanie; Kompella, Uday