GDUFA Research Outcomes
QCP Methods
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Pharmacokinetic Models for Inhaled Fluticasone Propionate and Salmeterol Xinafoate to Quantify Batch-to-Batch Variability
Li, Shuhui; Feng, Kairui; Lee, Jieon; Gong, Yuqing; Wu, Fang; Newman, Bryan; Yoon, Miyoung; Fang, Lanyan; Zhao, Liang; Gobburu, Jogarao
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Commentary on ‘Exploration of Suitable Pharmacodynamic Parameters for Acarbose Bioequivalence Evaluation: a Series of Clinical Trials with Branded Acarbose’ by Jie Huang et al
Zhang, Peijue; Lee, Jieon; Feng, Kairui; Babiskin, Andrew; Yoon, Miyoung; Fang, Lanyan; Zhao, Liang
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Model-Based Bioequivalence Approach for Sparse Pharmacokinetic Bioequivalence Studies: Model Selection or Model Averaging?
Philipp, Morgane; Tessier, Adrien; Donnelly, Mark; Fang, Lanyan; Feng, Kairui; Zhao, Liang; Grosser, Stella; Sun, Guoying; Sun, Wei-Jhe; Mentre, France; Bertrand, J
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Development and Comparison of Model-Integrated Evidence Approaches for Bioequivalence Studies with Pharmacokinetic End Points
Chen, Xiaomei; Nyberg, Henrik B; Donnelly, Mark; Zhao, Liang; Fang, Lanyan; Karlsson, Mats O; Hooker, Andrew C
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Evaluation of Model-Integrated Evidence Approaches for Pharmacokinetic Bioequivalence Studies using Model Averaging Methods
Nyberg, Henrik B; Chen, Xiaomei; Donnelly, Mark; Fang, Lanyan; Zhao, Liang; Karlsson, Mats O; Hooker, Andrew C
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Exploration of the Potential Impact of Batch-to-Batch Variability on the Establishment of Pharmacokinetic Bioequivalence for Inhalation Powder Drug Products
Li, Shuhui; Feng, Kairui; Lee, Jieon; Gong, Yuqing; Wu, Fang; Newman, Bryan; Yoon, Miyoung; Fang, Lanyan; Zhao, Liang; Gobburu, Jogarao
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Experience Learned and Perspectives on Using Model Integrated Evidence in the Regulatory Context for Generic Drug Products
Tsakalozou, Eleftheria; Fang, Lanyan; Bi, Youwei; Van Den Heuvel, Michiel; Ahmed, Tausif; Tsang, Yu Chung; Lionberger, Robert; Rostami-Hodjegan, Amin; Zhao, Liang
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Use of the Same Model or Modeling Strategy Across Multiple Submissions: Focus on Complex Drug Products
Walenga, Ross; Babiskin, Andrew; Bhoopathy, Sid; Clark, James F; De Backer, Jan; Ducharme, Murray; Kelly, Marc; Le Merdy, Maxime; Yoon, Miyoung; Roy, Partha
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RPEM: Randomized Monte Carlo Parametric Expectation Maximization Algorithm
Chen, Rong; Schumitzky, Alan; Kryshchenko, Alona; Nieforth, Keith; Tomashevskiy, Michael; Hu, Shuhua; Garreau, Romain; Otalvaro, Julian; Yamada, Walter; Neely, Michael N
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The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA
Fang, Lanyan; Gong, Yuqing; Hooker, A; Lukacova, Viera; Rostami-Hodjegan, Amin; Sale, Mark; Grosser, Stella; Jereb, Rebeka; Savic, Rada; Peck, Carl; Zhao, Liang