GDUFA Research Outcomes
Ophthalmic-Otic Products
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Regulating Generic Ophthalmologic Drug Bioequivalence—Envisioning Accessibility for Patients
Kozak, Darby
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Application of Mechanistic Ocular Absorption Modeling and Simulation to Understand the Impact of Formulation Properties on Ophthalmic Bioavailability in Rabbits: a Case Study Using Dexamethasone Suspension
Le Merdy, Maxime; Fan, Jianghong; Bolger, Michael; Lukacova, Viera; Spires, Jessica; Tsakalozou, Eleftheria; Patel, Vikram; Xu, Lin; Stewart, Sharron; Chockalingam, Ashok; Narayanasamy, Suresh; Rouse, Rodney; Matta, Murali; Babiskin, Andrew; Kozak, Darby
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Recent Advances in Topical Ocular Drug Delivery
Palakurthi, Srinath
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Ocular Physiologically Based Pharmacokinetic Modeling for Ointment Formulations
Lemerdy, Maxime; Spires, Jessica; Lukacova, Viera; Tan, Ming Liang; Babiskin, Andrew; Xu, Xiaoming; Zhao, Liang; Bolger, Michael
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A Kinetic Approach to Determining Drug Distribution in Complex Biphasic Systems
Dong, Yixuan; Hengst, Leanna; Patel, Deval; Hunt, Robert; Qu, Haiou; Choi, Stephanie; Ashraf, Muhammad; Cruz, Celia; Xu, Xiaoming
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Understanding Drug Distribution and Release in Ophthalmic Emulsions through Quantitative Evaluation of Formulation-Associated Variables
Dong, Yixuan; Hengst, Leanna; Hunt, Robert; Patel, Deval; Vo, Anh; Choi, Stephanie; Ashraf, Muhammad; Cruz, Celia; Xu, Xiaoming
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Engineering the Properties of Polymer Photonic Crystals with Mesoporous Silicon Templates
Wang, Joanna; Lee, Gha; Kennard, Rhiannon; Barillaro, Giuseppe; Bisiewicz, Rachel; Cortez Lemus, Norma; Cao, Xiaoyu; Anglin, Emily; Park, Jennifer; Potocny, Andrea; Bernhard, Drew; Li, Jianlin; Sailor, Michael
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LC-MS/MS method for simultaneous quantification of dexamethasone and tobramycin in rabbit ocular biofluids
Meng, Tuo; Kosmider, Leon; Chai, Guihong; Raynold, Aji Alex Moothedathu; Pearcy, Adam; Qin, Bin; Wang, Yan; Lu, Xiuling; Halquist, Matthew; Xu, Qingguo
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Effect of Particle Size and Viscosity of Suspensions on Topical Ocular Bioavailability of Budesonide, a Corticosteroid
Vooturi, Sunil; Bourne, David; Jyoti Panda, Jiban; Choi, Stephanie; Kim, Hyewon; Yandrapu, Sarath; Kompella, Uday
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Impact of Vehicle Physicochemical Properties on Modeling-Based Predictions of Cyclosporine Ophthalmic Emulsion Bioavailability and Tear Film Breakup Time
Walenga, Ross; Babiskin, Andrew; Zhang, Xinyuan; Absar, Mohammad; Zhao, Liang; Lionberger, Robert