GDUFA Research Outcomes
Complex Oral Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the oral route, including buccal and locally-acting gastrointestinal products.
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Quantitative Methods and Modeling to Evaluate Alternative Approaches for COVID-19 Interrupted Bioequivalence Studies
Zhao, Liang
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Leveraging Modeling and Simulation to Make Regulatory Impacts for Long-Acting Generic Drug Approvals
Zhao, Liang
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FEV1 Based Bioequivalence Study for Inhaled Corticosteroids
Zhao, Liang
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Use of Modeling and Simulation to Support New BE Approaches
Zhao, Liang
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Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA
Tampal, Nilufer
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Intestinal Influx Transporters: A Missing Piece in the Puzzle?
Zhang, Lei
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Regulatory and Scientific Considerations on Characterizations of Complex Polymeric Excipients
Wang, Yan
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Bioequivalence Approaches for Long-Acting Drug Products: Regulatory and Scientific Considerations
Wang, Yan
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Considerations and Expectations for in Vitro Release Testing of Complex Formulations
Wang, Yan
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Development of Generic Long Acting Injectables: Regulatory Challenges and Considerations
Wang, Yan