GDUFA Research Outcomes
QCP Methods
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Efficient model-based Bioequivalence Testing
Mollenhoff, Kathrin; Loingeville, Florence; Bertrand, Julie; Nguyen, Thu Thuy; Sharan, Satish; Zhao, Liang; Fang, Lanyan; Sun, Guoying; Grosser, Stella; Mentre, France; Dette, Holger
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Use of Partial Area Under the Curve in Bioavailability or Bioequivalence Assessments: A Regulatory Perspective
Fang, Lanyan; Uppoor, Ramana; Xu, Mingjiang; Sharan, Satish; Zhu, Hao; Tampal, Nilufer; Li, Bing; Zhang, Lei; Lionberger, Robert; Zhao, Liang
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Impact of Sex on Clinical Response in Rheumatoid Arthritis Patients Treated With Biologics at Approved Dosing Regimens
Fang, Lanyan; Song, Xuyang; Ji, Ping; Wang, Yaning; Maynard, Janet; Yim, Sarah; Sahajwalla, Chandrahas; Xu, Mingjiang; Kim, Myong Jin; Zhao, Liang
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Novel Bioequivalence Approach for Narrow Therapeutic Index Drugs
Yu, Lawrence; Jiang, Wenlei; Zhang, Xinyuan; Lionberger, Robert; Makhlouf, Fairouz; Schuirmann, Donald; Muldowney, Laurie; Chen, Meiling; Davit, Barbara; Conner, Dale; Woodcock, Janet
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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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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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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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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