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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Symposium 14: Applying Pharmacometrics to Precision Dosing in the Lifecycle of Long-acting Injectable Products: Drug Development, Regulatory Approval & Clinical Practice
Fang, Lanyan
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Marriage between Quantitative Approaches and Regulatory Science: A Reality Check on Where We Are
Fang, Lanyan
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Physiologically-Based Pharmacokinetic Pediatric Skin Model
Edginton, Andrea; Yun, Esther; Hamadeh, Abdullah
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Regulatory Challenges with Pharmacokinetic (PK) Bioequivalence (BE) Studies for Drugs Containing Endogenous Compounds
Donnelly, Mark
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Model-Integrated Evidence for Bioequivalence Assessment of Long-Acting Injectables from a Generic Drug Perspective
Yoon, Miyoung
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Model-Integrated Evidence for BE Assessment of Complex Generic Drugs
Yoon, Miyoung
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Pharmacometric Approach To Define Narrow Therapeutic Index (NTI) Drugs & Evaluate Bioequivalence (BE) Criteria for NTI Drugs
Dahmane, Elyes; Gobburu, Joga; Ivaturi, Vijay
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Use of Clinical Practice Data and PK/PD Modeling to Aid Classification of Narrow Therapeutic Index Drugs
Cohen-Wolkowiez, Michael
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Clinical Practice Data to Aid Narrow Therapeutic Index Drug Classification
Cohen-Wolkowiez, Michael
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Levetiracetam Characterization: Is it an NTI Drug?
Clarke, William