GDUFA Research Outcomes
QCP Methods
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Leveraging Quantitative Methods and Modeling to Modernize
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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Model-Integrated Bioequivalence Establishment: Long-Acting Injectable Drug Products
Yoon, Miyoung
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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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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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Recommendation of Partial Area Under the Curve (pAUC) Metrics in Product-Specific Guidance for Long-Acting Injectable (LAI) Drug Products
Thomas, Sherin
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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