GDUFA Research Outcomes
Data Analytics and AI
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to data analytics and artificial intelligence (AI) for generic product development and assessment, including the development of natural language processing (NLP) and machine learning (ML) tools
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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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Estimating Generic Drug Utilization With Electronic Health Records From A Mixed-Payer Ambulatory Healthcare Delivery System
Nimbal, Vani; Segal, Jodi; Romanelli, Robert
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Generic Competition And Authorized Generics In The Us
Moon, Jungyoon; Nkurunziza, Joseph; Jambi, Aseel; Seoane-Vazquez, Enrique; Qian, Jingjing; Hansen, Richard
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Patient Relevant Outcomes Associated With Generic Drugs In Fda’S Adverse Event Reporting System
Marimuthu, Sathiya; Iyer, Geetha; Segal, Jodi; Singh, Sonal
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Review of Advanced Analytical Methods in Complex Polymeric Drug Substance Characterization
Li, Shaohua; Zhang, Deyi; Kozak, Darby; Jiang, Xiaohui
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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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Assessing Therapeutic Equivalence of Brand and Generic Drugs Using Observational Data
Hunt, Lamar; Murimi, Irene; Scharfstein, Daniel; Mojtabai, Ramin; Varadhan, Ravi; Segal, Jodi
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Overcoming Temporal Confounding in the Assessment of Therapeutic Equivalence of Brand and Generic Drugs
Hunt, Lamar; Murimi, Irene; Scharfstein, Daniel; Mojtabai, Ramin; Varadhan, Ravi; Segal, Jodi
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A Statistical Bioequivalence Approach Based on Earth Mover’s Distance for Equivalence Testing of Particle Size Distribution
Hu, Meng; Jiang, Xiaohui; Absar, Mohammad; Choi, Stephanie; Shen, Meiyu; Weng, Yuting; Zhao, Liang; Lionberger, Robert
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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