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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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
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Using a Physiologically Based Pharmacokinetic Absorption Model to Establish Dissolution Bioequivalence Safe Space for Oseltamivir in Adult and Pediatric Populations
Wu, Fang
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EMA Discussion on Levothyroxine NTI Classification and BE Approach
Donnelly, Mark
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Partial Area Under Curve (pAUC): Product-Specific Guidance Development
Fang, Lanyan (Lucy)
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Applications and Lessons Learned for Conducting Adaptive Designs in Generic Drug Development
Feng, Kairui
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Comparative, Crossover PD Study of d|Different Formulations of Extended Release MPH
Spencer, Thomas; Biederman, Joseph; Faraone, SV; Childress, Ann; Gomeni, Roberto; Babiskin, Andrew; Fang, Lucy
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Virtual Bioequivalence Workflow
Pellowe, M
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Application of Quantitative Clinical Pharmacology (QCP) in Development of Long Acting Injectable Products
Sharan, Satish