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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What do We Know About PLGA Polymers in FDA-approved Drug Products: A Journey of Characterizing PLGA Polymers and Formulations
Qin, Bin; Wang, Yan; Zhang, Qiangnan; Li, Qi; Kozak, Darby
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Adaptive Perfusion: A Novel In Vitro Release Testing Method for Complex Ophthalmic Drug Products
Zhu, Dongkai; Zhang, Ying; Deval, Patel; Dong, Yixuan; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming
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AI-Assisted Tool to Improve the Quality and Assessment of PLGA Formulations
Das, Jayanti; Hasan, Md Easin; Smith, William; Graner, John; Qin, Bin; Wang, Yan; Park, Kinam; Tian, Geng; Xu, Xiaoming
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Impact of Variations in Critical Quality Attributes of Brinzolamide Ophthalmic Suspensions on Preclinical Pharmacokinetics and Pharmacodynamics Following Once Daily Topical Instillations
O’Reilly Beringhs, Andre; Naageshwaran, Vatsala; Gum, G; Seremak, D; Malla, S; Vo, A; Tan, Ming-Liang; Babiskin, Andrew; Wang, Yan; Kozak, Darby
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Automated Adaptive Perfusion: A Novel In Vitro Release Testing System for Complex Drug Products
Zhu, Dongkai; Zhang, Ying; 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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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