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-based Bioequivalence Evaluation for Ophthalmic Products Using Model Averaging Approaches
Chen, Xiaomei; Hooker, Andrew; Nyberg, Henrik; Karlsson, Mats
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Real-World Data Approaches for Early Detection of Potential Safety and Effectiveness Signals for Generic Substitution: A Metoprolol ExtendedRelease Case Study
Brown, Joshua
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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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Risk Factors Related to Relative Bioavailability Studies for Pediatric Products
Guy, Richard
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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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Assessing Bioequivalence for Generic Extended Release Formulations
Babiskin, Andrew