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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Identification Of Generic Drugs In The Fda Adverse Event Reporting System
Iyer, Geetha; Marimuthu, Sathiya; Segal, Jodi; Singh, Sonal
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Comparison Of Generic-To-Brand Switchback Patterns For Authorized Generic Vs. Independent Generic Drugs
Hansen, Richard; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane-Vazquez, Enrique; Dutcher, Sarah; Raofi, Saeid; Page, David; Peissig, Peggy
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Comparison of Clinical Outcomes Following a Switch From a Brand to an Authorized vs. Independent Generic Drug
Hansen, Richard; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane-Vazquez, Enrique; Dutcher, Sarah; Raofi, Saeid; Page, David; Peissig, Peggy
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Application of Physiologically-Based Oral Absorption & Pharmacokinetic Modeling to Investigate Formulation Factors Influencing the Pharmacokinetics of Novel Oral Anticoagulants
Farhan, Nashid; Basu, Sumit; Kim, Sarah; Lingineni, Karthik; Vozmediano, Valvanera; Ait-Oudhia, Sihem; Fang, Lanyan; Zhao, Liang; Lesko, Lawrence; Schmidt, Stephan
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Development of a Universal Pharmacogenetics-Guided Warfarin Dosing Nomogram
Deng, Jiexin; Arwood, Meghan; Duarte, Julio; Cavallari, Larisa; Schmidt, Stephan
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Integrated Data Mining And Systems Pharmacology To Explore The Comparative Safety Of Brand-Name And Generic Drugs
Biliouris, Konstantinos; Trame, Mirjam; Schmidt, Stephan; Fang, Lanyan; Lesko, Lawrence
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Integrated Data Mining And Systems Pharmacology To Explore The Comparative Safety Of Brand-Name And Generic Drugs
Biliouris, Konstantinos; Trame, Mirjam; Schmidt, Stephan; Fang, Lanyan; Lesko, Lawrence
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Physiologically Based Absorption Modeling as a Tool to Evaluate the Bioequivalence of Metoprolol ER Products
Basu, Sumit; Yang, Haitao; Fang, Lanyan; Sales, Mario; Zhao, Liang; Trame, Mirjam; Lesko, Lawrence; Schmidt, Stephan
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Clinical Implementation of Warfarin Pharmacogenetics In A Real-World Setting: A Proposal For A New Pharmacogenetic Dosing Approach For Diverse Patient Populations
Arwood, Meghan; Deng, Jiexin; Drozda, Katarzyna; Nutescu, Edith; Schmidt, Stephan; Duarte, Julio; Cavallari, Larisa
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Changes In Physician Prescribing Patterns In Response To Therapeutic Drug Monitoring Of Tacrolimus In Pediatric Patients.
Abdelaziz, S; Yu, T; Constance, J; Stockmann, C; Sherwin, C M T; M T; Constance, J E; Balch, A H