GDUFA Research Outcomes
QCP Methods
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Levetiracetam Characterization: Is it an NTI Drug?
Clarke, William
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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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Risk Factors Related to Relative Bioavailability Studies for Pediatric Products
Guy, Richard
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Regulatory Perspective on Modeling Strategies Across Multiple Submissions
Babiskin, Andrew; Yoon, Miyoung
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Assessing Bioequivalence for Generic Extended Release Formulations
Babiskin, Andrew
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Assessment of Repeated Crossover Bioequivalence Design Under Steady State Conditions
Zhang, Peijue; Donnelly, Mark; Feng, Kairui; Gong, Yuqing; Liu, Xiaofei; Babiskin, Andrew; Yoon, Miyoung; Zhao, Liang; Fang, Lanyan
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Model-Integrated Bioequivalence Method for Highly Variable Drugs with Long Half-Life: a Simulation Study Comparing Complete Washout and Incomplete Washout Designs
Huang, Zhe; Chen, Xiaomei; Donnelly, Mark; Fang, Lanyan; Zhao, Liang; Karlsson, Mats O; Hooker, AC
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Assessment of Repeated Crossover Bioequivalence Design Under Steady State Conditions
Zhang, Peijue; Donnelly, Mark; Feng, Kairui; Gong, Yuqing; Liu, Xiaolei; Babiskin, Andrew
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Performance of Machine Learning Algorithms for Model Selection
Li, Xinnong; Sale, Mark; Nieforth, Keith; Craig, James; Wang, Fenggong; Solit, David; Feng, Kairui; Hu, Meng; Bies, Robert; Zhao, Liang