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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Pitfalls and Challenges of Analyzing Particle Size Distribution in Ophthalmic Suspensions Using Laser Diffraction
Vo, Anh; Feng, Xin; Kozak, Darby; Choi, Stephanie; Xu, Xiaoming
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Development of an Ocular Physiologically-Based Pharmacokinetic Model to Describe the Impact of Formulation Attributes on the Disposition of an Antibiotic Applied on the Rabbit Eye
Tsakalozou, Eleftheria; LeMerdy, Maxime; Babiskin, Andrew; Zhao, Liang
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Physical Formulation Features and Ocular Absorption from Topical Suspensions: Toward Mechanistic Understanding
Toropainen, Elisa; Novakovic, Dunja; Fraser, Sara; Tuomainen, Marjo; Hagstrm, Marja; Amo, Eva del; Vellonen, Kati-Sisko; Peltoniemi, Jonne; Tengvall, Unni; Pelkonen, Laura; Reinisalo, Mika; Ruponen, Marika; Auriola, Seppo; Viitala, Tapani; Absar, Mohammad
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Impact of Particle Flocculation on Dissolution and Implications on Bioavailability of Injectable Suspensions
Smith, William; Bae, Jungeun; Zhang, Ying; Wang, Yan; Qin, Bin; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming
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Interplay Between Particle Flocculation and Dissolution Leading to Variation in Bioavailability and Clinical Performance of Injectable Suspensions
Smith, William; Bae, Jungeun; Zhang, Ying; Wang, Yan; Qin, Bin; Kozak, Darby; Xu, Xiaoming
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Impact of Particle Flocculation on Determination of Bioequivalence and Clinical Performance of Injectable Suspensions
Smith, William; Bae, Jungeun; Zhang, Ying; Wang, Yan; Qin, Bin; Kozak, Darby; Xu, Xiaoming
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Influence of polymeric excipients on the precision of particle size distribution measurements of suspensions using laser diffraction
Smith, William; Vo, Anh; Bae, Jungeun; Wang, Yan; Qin, Bin; Xu, Xiaoming
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Influence of polymeric excipients on the precision of particle size distribution measurements of suspensions using laser diffraction
Smith, William; Vo, Anh; Bae, Jungeun; Wang, Yan; Qin, Bin; Kozak, Darby; Xu, Xiaoming
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Asymmetical-flow Field Fractionation to Assess the Impact of Manufacturing Process Variables on the Globule Size of Distribution of Cyclosporine Emulsions
Qu, Haiou; Patel, Deval; Kozak, Darby; Walenga, Ross; Choi, Stephanie; Ashraf, Muhammad; Faustino, Patrick; Cruz, Celia; Xu, Xiaoming
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Asymmetric Flow Field Flow Fractionation as an Analytical Tool for the Size Based Separation and Characterization of Complex Ophthalmic Emulsions
Qu, Haiou; Wang, Jiang; Wu, Yong; Zheng, Jiwen; Yellela, Krishnaiah; Absar, Mohammad; Choi, Stephanie; Ashraf, Muhammad; Cruz, Celia; Xu, Xiaoming