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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Exploration the Potential Impact of Batch-to-Batch Variability of Inhalation Powder Drug Products on Pharmacokinetic Bioequivalence Study Power
Li, Shuhui; Feng, Kairui; Lee, Jieon; Gong, Yuqing; Wu, Fang; Newman, Bryan; Yoon, Miyoung; Fang, Lanyan; Zhao, Liang; Gobburu, Joga
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Applications of Adaptive Designs in Generic Drug Development
Lee, Jieon; Feng, Kairui; Xu, Mingjiang; Gong, Xiajing; Sun, Wanjie; Kim, Jessica; Zhang, Zhen; Wang, Meng; Fang, Lanyan; Zhao, Liang
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The Effect of PLGA Molecular Weight on Drug Release from Microspheres
Kohno, Moe; Andhariya, Janki; Rothstein, Sam; Wang, Yan; Qin, Bin; Burgess, Diane
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Quantitative Assessment of Additional Metrics in the Bioequivalence Evaluation of Oxcarbazepine Extended-Release Tablet
Kim, Hyewon; Fang, Lanyan; Zhao, Liang
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Clinical Practice Data To Aid Narrow Therapeutic Index Drug Classification: Lamotrigine
Guptill, Jeffrey; Wu, Huali; Greenberg, Rachel; Gostelow, Martyn; Gonzalez, Daniel; Hornik, Christoph; Zheng, Nan; Jiang, Wenlei; Cohen-Wolkowiez, Michael; Hill, Kevin
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Model-Based Tests of Bioequivalence: Impact of a Model Misspecification
Guhl, Melanie; Mercier, F; Sharan, Satish; Feng, Kairui; Sun, G; Sun, W; Grosser, S; Zhao, Liang; Fang, Lanyan; Mentre, F; Comets, E; Bertrand, J
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Model-Based Tests of Bioequivalence: Impact of a Model Misspecification
Guhl, Melanie; Mercier, F; Sharan, Satish; Feng, Kairui; Sun, G; Sun, W; Grosser, S; Zhao, Liang; Fang, Lanyan; Mentre, F; Comets, E; Bertrand, J
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Age Is a Statistically Significant Predictor of the Within Subject Variability in Dabigatran Pharmacokinetics
Gonzalez-Sales, Mario; Fan, Jianghong; Fang, Lanyan; Hu, Meng; Lionberger, Robert; Zhao, Liang
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Model Based Exposure-Response Analysis of Rivaroxaban to Assess the Adequacy of Current Bioequivalence Limits in Generic New Oral Anticoagulant Drugs
Gonzalez-Sales, Mario; Mario; Fang, Lanyan; Kim, Myongjin; Zhao, Liang
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Quantitative Modeling and Simulation to Evaluate Alternative Approaches to be Used in COVID-19 Interrupted Bioequivalence Studies
Gong, Yuqing; Feng, Kairui; Lee, Jieon; Pan, Yuzhuo; Bai, Tao; Li, Bing; Kim, Carol; Yoon, Miyoung; Zhang, Peijue; Fang, Lanyan; Zhao, Liang