GDUFA Research Outcomes
BE Methods and Analyses
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to bioequivalence methods and analyses for generic drug products.
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Evaluation of U.S. FDA Approved Generic Oral Solution Products
Hakeem, Susan; Huang, Yih-Chain; Jiang, Wenlei
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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
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Phase Behavior and Tranformation Kinetics of A Poorly Water Soluble Weakly Basic Drug upon Transit from Low to High PH Conditions
Duong, Tu; Turner, David; Taylor, Lynne
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Formulation Design Considerations And Pharmacokinetics Assessments Of Bupropion Drug Products
Connarn, Jamie; Li, Yan; Zhou, Simon; Zhang, Xinyuan; Babiskin, Andrew; Fan, Jianghong; Amini, Thushi; Sun, Duxin
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Metabolic Kinetics of Bupropion in Human Liver and Intestinal Subcellular Fractions
Sun, Duxin
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PBPK Modeling for Predicting the In Vivo Performance and Product Quality of Tacrolimus and Itraconazole Amorphous Solid Dispersions in Humans
Chow, Edwin; Sun, Dajun; Fang, Lanyan; Wen, Hong; Zhao, Liang; Lapteva, Larissa; Jiang, Wenlei; Lionberger, Robert
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Assessment on the Formulation Similarity of Approved Generic Drug Products and their Respective Reference Products Which are Considered as Potential BCS Class 3 Drugs
Chan, Theresa; Ren, Ping; Yang, Wen Cheng; Wang, Yan; Luke, Markham; Kim, Myong Jin; Zhang, Yi
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Excipient Similarity in Generic Formulations Containing Biopharmaceutics Classification System 3 Drugs
Chan, Theresa; Ren, Ping; Yang, Wencheng; Wang, Yan; Luke, Markham; Jiang, Xiaohui; Zhang, Yi
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Using the In-vitro Dissolution Absorption System (IDAS) to Evaluate the Effects of Excipients on the Permeation of Putative Biopharmaceutics Classification System Class III Drugs
Bode, Chris; Bhoopathy, Sid; Miezeiewski, Blair; Wu, Fang; Ren, Ping; Wang, Zhong; Zhao, Liang
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In Vitro Comparative Dissolution and Permeation Testing Using the In-vitro Dissolution Absorption System (IDAS) for Expanding Biowaivers to Non Q1/Q2 BCS Class III Products
Bode, Chris; Bhoopathy, Sid; Miezeiewski, Blair; Wu, Fang; Ren, Ping; Wang, Zhong; Zhao, Liang