GDUFA Research Outcomes
BE Methods & 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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Scientific considerations to move towards biowaiver for biopharmaceutical classification system class III drugs: How modeling and simulation can help
Wu, Fang; Cristofoletti, Rodrigo; Zhao, Liang; Rostami-Hodjegan, Amin
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Reply to “On the Effect of Common Excipients on the Oral Absorption of Class 3 Drugs”
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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Gastric Emptying and Intestinal Appearance of Nonabsorbable Drugs Phenol Red and Paromomycin in Human Subjects: A Multi-Compartment Stomach Approach
Paixao, Paulo; Bermejo, Marival; Hens, Bart; Tsume, Yasuhiro; Dickens, 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; Sun, D; Amidon, G L
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Transporters in Regulatory Science: Notable Contributions from Dr. Giacomini in the Past Two Decades
Zhang, Lei; Liu, Qi; Huang, Shiew Mei; Lionberger, Robert
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The Evaluation of In Vitro Drug Dissolution of Commercially Available Oral Dosage Forms for Itraconazole in Gastrointestinal Simulator with Biorelevant Media
Matsui, Kazuki; Tsume, Yasuhiro; Amidon, Gregory; Amidon, Gordon
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In Vivo Dissolution and Systemic Absorption of Immediate Release Ibuprofen in Human Gastrointestinal Tract under Fed and Fasted Conditions
Koenigsknecht, Mark; Baker, Jason; Wen, Bo; Frances, Ann; Zhang, Huixia; Yu, Alex; Zhao, Ting; Tsume, Yasuhiro; Pai, Manjunath; Bleske, Barry; Zhang, Xinyuan; Lionberger, Robert; Lee, Allen; Amidon, Gordon; Hasler, William; Sun, Duxin
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Physiologically Based Pharmacokinetic Modeling for Substitutability Analysis of Venlafaxine Hydrochloride Extended-Release Formulations Using Different Release Mechanisms: Osmotic Pump Versus Openable Matrix
Lin, Hopi; Sun, Dajun; Zhang, Xinyuan; Wen, Hong
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Non-Sink Dissolution Conditions for Predicting Product Quality and In Vivo Performance of Supersaturating Drug Delivery Systems
Sun, Dajun; Wen, Hong; Taylor, Lynne
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A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion
Jiang, Wenlei; Makhlouf, Fairouz; Schuirmann, Donald; Zhang, Xinyuan; Zheng, Nan; Conner, Dale; Yu, Lawrence; Lionberger, Robert
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A Protocol for Assay of Poly(lactide-co-glycolide) in Clinical Products
Garner, John; Skidmore, Sarah; Park, Haesun; Park, Kinam; Choi, Stephanie; Wang, Yan