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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Application of Ocular Physiologically Based Pharmacokinetic Modeling to Understand the Impact of Particle Size and Viscosity on Ophthalmic Bioavailability of Tobradex ST Suspension in Rabbits
Lemerdy, Maxime; Tsakalozou, Eleftheria; Choi, Stephanie; Kim, Myongjin; Xu, Lin; Stewart, Sharron; Chockalingam, Ashok; Rouse, Rodney; Matta, Murali; Zhao, Liang; Lionberger, Robert; Fan, Jianghong
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Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Moxifloxacin Solution Case Study
Le Merdy, Maxime; Lukacova, Viera; Tan, Ming-Liang; Babiskin, Andrew; Zhao, Liang
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Impact of Changes in Ophthalmic Emulsion Globule Size Distribution and Viscosity on Tear Film Thickness and Menisci Characteristics
Kumar, Sandeep; Cook, Nicholas; Gum, Glenwood; Manza, Linda; Naageshwaran, Vatsala; Lyulkin, Mathew; Xu, Xiaoming; Patel, Deval; Qu, Haiou; Walenga, Ross; Tan, Ming Liang; Babiskin, Andrew; Kaisar, Mohmmad Abul
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Towards Development of In Vitro Drug Release Methods for Difluprednate Ophthalmic Emulsion
Hidau, Mahendra; Mehra, Neelesh; Absar, Mohammad; Choi, Stephanie; Potter, David; Palakurthi, Srinath
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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