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