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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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 Modeling of Complex Products
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
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Application of Quantitative Methods and Modeling to Generic Drug Development
Zhao, Liang
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Foundations of PK Comparisons of Generic Opioids to RLDs with Labeling Describing Abuse-deterrent Properties
Zhao, Liang
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Leveraging Quantitative Methods and Modeling to Modernize
Zhao, Liang
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Model-Integrated Bioequivalence Establishment: Long-Acting Injectable Drug Products
Yoon, Miyoung