GDUFA Research Outcomes
Ophthalmic-Otic Products
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Impact of Apparatus and Adaptor Setups on In Vitro Drug Release of Ophthalmic Semi-Solid Drug Products
Zhen, Zixuan; Mekjaruskul, Catheleeya; Qin, Bin; Wang, Yan; Lu, Xiuling
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Adaptive Perfusion: An In Vitro Drug Release Testing Method for Complex Drug Products
Zhang, Ying; Patel, Deval; Zhu, Dongkai; Dong, Yixuan; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming
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Adaptive Perfusion: A Novel In Vitro Drug Release Testing Method for Complex Drug Products
Zhang, Ying; Patel, Deval; Zhu, Dongkai; Dong, Yixuan; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming
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Adaptive Perfusion: An In Vitro Drug Release Testing Method for Complex Drug Products
Zhang, Ying; Patel, Deval; Zhu, Dongkai; Dong, Yixuan; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming
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Novel Method for Bench-top 19F NMR in Measuring API Phase Partition for Oil-in-Water Emulsion Drug Products
Wang, Xinyi; Patil, Sharadrao; Chen, Kang
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Modeling Approach for Assessing the Impact of Physicochemical Properties on Bioequivalence of Cyclosporine Ophthalmic Emulsion
Walenga, Ross; Babiskin, Andrew; Absar, Mohammad; Zhang, Xinyuan; Zhao, Liang; Lionberger, Robert
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Effect of Physicochemical Properties of Q1/Q2 Ophthalmic Suspensions on Ocular Bioavailability and Bioequivalence
Vooturi, S; Bourne, D; Panda, J; Choi, S; Kim, H; Yandrapu, S; Kompella, U
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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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Impact of Manufacturing Processes on Critical Quality Attributes of Brinzolamide Ophthalmic Suspensions
Vo, Anh; Feng, Xin; Patel, Deval; Patel, Mehulkumar; Kozak, Darby; Choi, Stephanie; Zheng, Jiwen; 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