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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Mechanistic Analysis of Triamcinolone Acetonide Release from PLGA Microspheres as a Function of Varying in Vitro Release Conditions
Doty, Amy; Zhang, Ying; Weinstein, David; Wang, Yan; Choi, Stephanie; Qu, Wen; Mittal, Sachin; Schwendeman, Steven
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Exploring Gastrointestinal Variables Affecting Drug and Formulation Behavior: Methodologies, Challenges and Opportunities
Hens, Bart; Corsetti, Maura; Spiller, Robin; Marciani, Luca; Vanuytsel, Tim; Tack, Jan; Talattof, Arjang; Amidon, Gordon; Koziolek, Mirko; Weitschies, Werner; Wilson, Clive; Bennink, Roelof; Brouwers, Joachim; Augustijns, Patrick
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Physiologically Based Pharmacokinetic and Absorption Modeling for Osmotic Pump Products
Ni, Zhanglin; Talattof, Arjang; Fan, Jianghong; Tsakalozou, Eleftheria; Sharan, Satish; Sun, Duxin; Wen, Hong; Zhao, Liang; Zhang, Xinyuan
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Dissolution Test of Tacrolimus Capsule: Effects of Filtration and Glass Adsorption
Zeng, Kui; Gao, Zongming; Trehy, Michael; Jiang, Wenlei
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Evaluation of the Crystallization Tendency of Commercially Available Amorphous Tacrolimus Formulations Exposed to Different Stress Conditions
Trasi, Niraj; Purohit, Hitesh; Taylor, Lynne
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Switch-Backs Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence
Gagne, Joshua; Polinski, Jennifer; Jiang, Wenlei; Dutcher, Sarah; Xie, Jing; Lii, Joyce; Fulchino, Lisa; Kesselheim, Aaron
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Innovative Approaches for Demonstration of Bioequivalence: the US FDA Perspective
Zhang, Xinyuan; Zheng, Nan; Lionberger, Robert; Yu, Lawrence
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A Critical Overview of the Biological Effects of Excipients (Part I): Impact on Gastrointestinal Absorption
Martinez, M N; Sinko, B; Wu, F; Flanagan, T; Borbas, E; Tsakalozou, Eleftheria; Giacomini, K M
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Bacterial metabolism rescues the inhibition of intestinal drug absorption by food and drug additives
Zou, Ling; Spanogiannopoulos, Peter; Peiper, Lindsey; Chein, Huan Chieh; Cai, Wenlong; Khuri, Natalia; Pottel, Joshua; Vora, Bianca; Ni, Zhanglin; Tsakalozou, Eleftheria; Zhang, Wenjun; Schoichet, Brian; Giacomini, Kathleen; Turnbaugh, Peter
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Prevalence and Predictors of Generic Drug Skepticism among Physicians: Results of a National Survey
Kesselheim, Aaron; Gagne, Joshua; Eddings, Wesley; Franklin, Jessica; Ross, Kathryn; Fulchino, Lisa; Campbell, Eric