GDUFA Research Outcomes

Data & 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

• All(125)
• Posters(29)
• Presentations(37)
• Papers(59)

• 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

• Estimating Generic Drug Utilization With Electronic Health Records From A Mixed-Payer Ambulatory Healthcare Delivery System

  Nimbal, Vani; Segal, Jodi; Romanelli, Robert

• Generic Competition And Authorized Generics In The Us

  Moon, Jungyoon; Nkurunziza, Joseph; Jambi, Aseel; Seoane-Vazquez, Enrique; Qian, Jingjing; Hansen, Richard

• Patient Relevant Outcomes Associated With Generic Drugs In Fda’S Adverse Event Reporting System

  Marimuthu, Sathiya; Iyer, Geetha; Segal, Jodi; Singh, Sonal

• Review of Advanced Analytical Methods in Complex Polymeric Drug Substance Characterization

  Li, Shaohua; Zhang, Deyi; Kozak, Darby; Jiang, Xiaohui

• Identification Of Generic Drugs In The Fda Adverse Event Reporting System

  Iyer, Geetha; Marimuthu, Sathiya; Segal, Jodi; Singh, Sonal

• Assessing Therapeutic Equivalence of Brand and Generic Drugs Using Observational Data

  Hunt, Lamar; Murimi, Irene; Scharfstein, Daniel; Mojtabai, Ramin; Varadhan, Ravi; Segal, Jodi

• 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

• 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

• 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