GDUFA Research Outcomes
QCP Methods
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to quantitative clinical pharmacology assessments of oral absorption to support generic product development and assessment.
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Use of Partial AUC to Demonstrate Bioequivalence of Zolpidem Tartrate Extended Release Formulations
Lionberger, Robert; Raw, Andre; Kim, Stephanie; Zhang, Xinyuan; Yu, Lawrence
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Best Practices to Leverage Model-Integrated Evidence and Model Master File Packages to Bring Complex Generics to Market
Ghosh, Priyanka
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Application of Quantitative Clinical Pharmacology in the Development of Long-Acting Injectable (LAI) Drug Products
Zhao, Liang
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Quantitative Methods and Modeling to Evaluate Alternative Approaches for COVID-19 Interrupted Bioequivalence Studies
Zhao, Liang
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General Overview: The Use of Quantitative Methods and Modeling to Facilitate Generic Drug Development and Regulatory Assessment
Zhao, Liang
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Model Integrated Evidence as Pivotal Information for Drug Regulatory Decision Making: When, Where, and Why From Generic Drug Perspective
Zhao, Liang
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Quantitative Analysis of Opioid ADF PK/PD
Zhao, Liang
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Review of Quantitative Modelling of Complex Products
Zhao, Liang
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Craft the Art of Using Quantitative Methods and Modeling for Drug Development
Zhao, Liang
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Overview of GDUFA-funded Modeling and Simulation Grants/Contracts
Zhao, Liang