GDUFA Research Outcomes
Post-Approval Monitoring
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to post-approval monitoring of generic products.
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Release of Levetiracetam from Extended-Release Tablets that Appear Intact in Patient Stool
Vaithianathan, Soundarya; Ting, Tricia; Jiang, Wenlei; Polli, James
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Healthy User Bias in Comparative Safety Studies for Brand-Name vs. Generic Products: The Example of Warfarin
Bird, Steven; Flowers, Natasha; Zhao, Yueqin; Mckean, Stephen; Izem, Rima; Wernecke, Michael; Kozlowski, Steven; Macurdy, Thomas; Kelman, Jeffrey; Graham, David
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Model-Based Approach for Optimizing Study Design and Clinical Drug Performances of Extended-Release Formulations of Methylphenidate for the Treatment of Attention-Deficit Hyperactivity Disorder
Gomeni, Roberto; Lucy, Fang; Bressolle Gomeni, Françoise; Spencer, Thomas; Faraone, Stephen; Babiskin, Andrew
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Evaluation of Switching Patterns in FDA’s Sentinel System: A New Tool to Assess Generic Drugs
Gagne, Joshua; Popovic, Jennifer; Nguyen, Michael; Sandhu, Sukhminder; Greene, Patty; Izem, Rima; Jiang, Wenlei; Wang, Zhong; Zhao, Yueqin; Petrone, Andrew; Wagner, Anita; Dutcher, Sarah
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Determinants Of Generic Drug Substitution In The United States
Segal, Jodi; Onasanya, Oluwadamilola; Daubresse, Matthew; Lee, Chia Ying; Moechtar, Mischka; Pu, Xia; Dutcher, Sarah; Romanelli, Robert
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Genotype-Guided Dosing of Warfarin through Modeling and Simulation
Deng, Jiexin; Vozmediano, Valvanera; Rodriguez, Monica; Cavallari, Larisa; Schmidt, Stephan
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Differences in Rates of Switchbacks after Switching from Branded to Authorized Generic and Branded to Generic Drug Products: Cohort Study
Desai, Rishi; Sarpatwari, Ameet; Dejene, Sara; Khan, Nazleen; Lii, Joyce; Rogers, James; Dutcher, Sarah; Raofi, Saeid; Bohn, Justin; Connolly, John; Fischer, Michael; Kesselheim, Aaron; Gagne, Joshua
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Real-World Data Approaches for Early Detection of Potential Safety and Effectiveness Signals for Generic Substitution: A Metoprolol Extended-Release Case Study
Brown, Joshua; Henriksen, Carl; Vozmediano, Valvanera; Schmidt, Stephan
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Oral Generic Tacrolimus Initiation and Substitution in the Medicaid Population: A New User Cohort Study
Chen, Li; Li, Chao; Huo, Nan; Mishuk, Ahmed; Hansen, Richard; Harris, Ilene; Kiptanui, Zippora; Qian, Jingjing