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 Effects of Excipients on Intestinal Drug Transporters
Giacomini, Kathy
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Updates to the Simcyp Simulator’s ADAM / M-ADAM Models
Turner, David
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Modeling Gastrointestinal Lumical Drug Precipitation
Turner, David
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In Vitro Drug Release Testing for Complex Generics: A Bioequivalence Perspective
Wang, Yan
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Potential Impact of Gastric pH on Generic Drug Bioequivalence Evaluation
Fan, Jianghong
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PBPK Absorption Modeling to Support Risk Assessment and Biowaiver for Generic Oral Products
Wu, Fang
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Regulatory Challenges with Pharmacokinetic (PK) Bioequivalence (BE) Studies for Drugs Containing Endogenous Compounds
Donnelly, Mark
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Regulatory Research on the Effect of Excipients on Drug Absorption
Zhang, Lei
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Hydrodynamic Enhancement of Dissolution from Drug Particles: In Vivo vs. In Vitro
Brasseur, James.; Wang, Yanxing
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Essential Elements of BCS III-Based Biowaiver Request
Zhang, Yi