GDUFA Research Outcomes
MR Oral Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to modified release 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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Effect of Simulated Gastrointestinal Contraction on Drug Release of Nifedipine Extended-Release Tablet
Gao, Zongming; Ye, Wei; Tian, Li; Rodriguez, Jason
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Mechanical Response of Nifedipine Extended-release Tablet During in Vitro Dissolution Testing
Gao, Zongming; Ngo, Diem; Ye, Wei; Rodriguez, Jason; Keire, David; Sun, Dajun; Wen, Hong; Jiang, Wenlei
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Use of Partial AUC to Demonstrate Bioequivalence of Generic Methylphenidate Extended-release Products using Physiologically Based Absorption Modeling and Simulation
Babiskin, Andrew; Fang, Lanyan; Lapteva, Larissa; Jiang, Wenlei; Lionberger, Robert; Kim, Hyewon
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A Retrospective Analysis of Pharmacokinetic Variability Between Fasting and Fasting-Sprinkle Bioequivalence Studies of Generic Modified-Release Drug Products: A Case Study on Esomeprazole Magnesium
Abdallah, Ihab; Gabal, Yasmine; Boyce, Heather; Zhu, Jing; Kim, Myong-Jin.
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A Retrospective Analysis of Pharmacokinetic Variability Between Fasting and Fasting-Sprinkle Bioequivalence Studies of Generic Modified-Release Drug Products: A Case Study on Esomeprazole Magnesium
Abdallah, Ihab; Gabal, Yasmine; Boyce, Heather; Zhu, Jing; Kim, Myong Jin