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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Post-marketing Surveillance of Generic Drug Usage and Substitution Patterns
Zuckerman, Ilene; Pradel, Francoise; Palumbo, Francis; Shen, Xian; Kiptanui, Zippora; Polli, James; Gardner, Jim; Franey, Christine; Malik, Sana
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Development of a Physiologically Based Pharmacokinetic Model of Tacrolimus in Adult Organ Transplant Patients.
Yu, Tian; Rower, Joseph; Liu, Xiaoxi; Balch, Alfred; Halford, Zachery; Korgenski, E. Kent; Sherwin, Catherine
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Population Pharmacokinetics Of Tacrolimus In Pediatric Heart Transplant Patients.
Yu, Tian; Liu, Xiaoxi; Balch, Alfred; Molina, Kimberly; Constance, Jonathan; Prevedel, Jamie; Korgenski, E.Kent; Spigarelli, Michael; Sherwin, Catherine
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Determinants Of Generic Drug Substitution In The United States
Segal, Jodi; Daubresse, Matthew; Onasanya, Olukayode
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Therapeutic Class Differences In Generic Usage
Segal, Jodi; Daubresse, Matthew; Lee, Chiaying; Dutcher, Sarah; Jiang, Wenlei; Moechtar, Mischka; Romanelli, Robert
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Use Of Physiologically Based Pharmacokinetic Modeling As A Computational And Mathematical Tool To Evaluate Switchability Of Generic And Brand Name Products
Samant, Tanay; Schmidt, Stephan; Fang, Lanyan; Chow, Edwin; Trame, Mirjam; Lesko, Lawrence
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Generic Substitution Patterns of Levothyroxine and Escitalopram in Subgroups of U.S. Medicare Beneficiaries
Qian, Jingjing; Li, Chao; Huo, Nan; Mishuk, Ahmed; Chen, Li; Hansen, Richard; Harris, Ilene; Kiptanui, Zippora
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Comparing Clinical Outcomes Of Brand And Generic Drugs: Systematic Literature Review Of Acarbose, Calcitonin Nasal Spray And Venlafaxine Er Tablets
Park, Jina-Yujin; Kiptanui, Zippora; Palumbo, Francis; Zuckerman, Ilene; Pradel, Francoise; Khokhar, Bilal; Jiang, Wenlei; Cai, Wendy; Dutcher, Sarah
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Clinical Practice Patterns and Potential Barriers to Generic Drug Use in Special Populations
Ogbenna, Bethany; Kiptanui, Zippora; Harris, Ilene; Dyrmishi, Jola; Dowell, Paul; Qian, Jingjing; Hansen, Richard
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Estimating Generic Drug Utilization With Electronic Health Records From A Mixed-Payer Ambulatory Healthcare Delivery System
Nimbal, Vani; Segal, Jodi; Romanelli, Robert