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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The Interplay Between Pharmaceutical Dissolution and Absorption in the Human Gut Studied with Computer Simulation
Behafarid, F; Vijayakumar, G; Brasseur, J G
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Assessing the Bioequivalence of Tacrolimus Amorphous Formulations with Varying Degrees of Crystallinity using Mechanistic Dissolution Models in a Population Physiologically-based Pharmacokinetic (PBPK) Modelling Framework
Arora, Sumit; Patel, Nikunjkumar; Jamei, Masoud; Turner, David
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Fasted State Motility-Dependent Transit And Dissolution Of Ibuprofen.
Amidon, G L
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Assessing the Impact of Excipient and Food Intake on Bioequivalence Using PBPK and Virtual Bioequivalence Trial: A Case Example with Acyclovir Immediate Release Tablets
Al Shoyaib, Abdullah; Fang, Lanyan; Zhao, Liang; Wu, Fang