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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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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Model Based Assessment Using Conventional BE Limits to Ensure Safety and Efficacy of Rivaroxaban in Patients Undergoing Hip or Knee Replacement
Gonzalez Sales, Mario; Fang, Lanyan; Kim, Myongjin; Zhao, Liang
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Using Partial Area for Evaluation of Bioavailability and Bioequivalence
Chen, Meiling; Davit, Barbara; Lionberger, Robert; Wahba, Zakaria; Ahn, Haeyoung; Yu, Lawrence
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Therapeutic Drug Monitoring, Electronic Health Records, and Pharmacokinetic Modeling to Evaluate Sirolimus Drug Exposure-Response Relationships in Renal Transplant Patients
Zimmerman, Kanecia; Wu, Huali; Greenberg, Rachel; Guptill, Jeffrey; Hill, Kevin; Patel, Uptal; Ku, Lawrence; Gonzalez, Daniel; Hornik, Christoph; Jiang, Wenlei; Zheng, Nan; Melloni, Chiara; Cohen Wolkowiez, Michael
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New Model-Based Bioequivalence Statistical Approaches for Pharmacokinetic Studies with Sparse Sampling
Loingeville, Florence; Bertrand, Julie; Nguyen, Thu Thuy; Sharan, Satish; Feng, Kairui; Sun, Wanjie; Han, Jing; Grosser, Stella; Zhao, Liang; Fang, Lanyan; Mollenhoff, Kathrin; Dette, Holger; Mentre, France
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Impact of Model Misspecification on Model-Based Tests in PK Studies with Parallel Design: Real Case and Simulation Studies
Guhl, Melanie; Mercier, Francois; Hofmann, Carsten; Sharan, Satish; Donnelly, Mark; Feng, Kairui; Sun, Wanjie; Sun, Guoying; Stella, Grosser; Zhao, Liang; Fang, Lanyan; Mentre, France; Comets, Emmanuelle; Bertrand, Julie
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Use of Partial AUC to Demonstrate Bioequivalence of Zolpidem Tartrate Extended Release Formulations
Lionberger, Robert; Raw, Andre; Kim, Stephanie; Zhang, Xinyuan; Yu, Lawrence