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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Impact of Excipient Grade (Q1/Q2) on the Bioequivalence of Generic Drug Products
Choi, Stephanie
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Locally Acting Drug Products: Bioequivalence Challenges and Opportunities
Choi, Stephanie
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An Update on FDA’s Research Program for Ophthalmic Generic Products
Choi, Stephanie
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Bioequivalence Requirements for Ophthalmic Products: CMC and Clinical/Pharmacokinetic Considerations
Choi, Stephanie
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Developing PBPK for Ocular Delivery
Bolger, Michael
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Equivalence of Complex Products Cyclosporine Ophthalmic Emulsion
Gong, Xiajing
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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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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: 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: 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