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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Gastrointestinal Motility Variation and Implications for Plasma Level Variation: Oral Drug Products
Talattof, Arjang; Price, Judy; Amidon, Gordon
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Linking the Gastrointestinal Behavior of Ibuprofen with the Systemic Exposure between and within Humans-Part 2: Fed State
Paixao, Paulo; Bermejo, Marival; Hens, Bart; Tsume, Yasuhiro; Dicken, Joseph; Shedden, Kerby; Salehi, Niloufar; Koenigsknecht, Mark; Baker, Jason; Hasler, William; Lionberger, Robert; Fan, Jianghong; Wysocki, Jeffrey; Wen, Bo; Lee, Allen; Frances, Ann; Amidon, G E; Yu, A; Benninghoff, G; Lobenberg, R; Talattof, A; Su, D; Amidon, G L
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Effect of Common Excipients on the Oral Drug Absorption of Biopharmaceutics Classification System Class 3 Drugs Cimetidine and Acyclovir
Vaithianathan, Soundarya; Haidar, Sam; Zhang, Xinyuan; Jiang, Wenlei; Avon, Christopher; Dowling, Thomas; Shao, Changxing; Kane, Maureen; Hoag, Stephen; Flasar, Mark; Ting, Tricia; Polli, James
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Interactions of Azo Dyes Commonly Used in Oral Drug Products with the Organic Anion Transporting Polypeptide 2B1 (OATP2B1) and Human Gut Bacteria
Zou, Ling
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Biopharmaceutic In Vitro In Vivo Extrapolation (IVIV_E) Informed Physiologically-Based Pharmacokinetic Model of Ritonavir Norvir Tablet Absorption in Humans Under Fasted and Fed State Conditions
Arora, Sumit
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Screening Oral Excipients against P-glycoprotein
Bajaj, Ruchika
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Quantitative Methods and Modeling to Evaluate Alternative Approaches for COVID-19 Interrupted Bioequivalence Studies
Zhao, Liang
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FEV1 Based Bioequivalence Study for Inhaled Corticosteroids
Zhao, Liang
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Use of Modeling and Simulation to Support New BE Approaches
Zhao, Liang
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Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA
Tampal, Nilufer