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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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