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

• All(101)
• Posters(25)
• Presentations(27)
• Papers(49)

• 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 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

• 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

• Area-level Socioeconomic Status Indicators for Observational Studies of Medication User: A Comparison of Zip Code and Cencus-block Group Based Aggregation

  Gopalakrishnan, Chandrasekar; Gagne, Joshua; Sarpatwari, Ameet; Dejene, Sara; Dutcher, Sarah; Levin, Raisa; Franklin, Jessica; Desai, Rishi

• Revealing Association between Kinases and Adverse Events for Small-Molecule Tyrosine Kinase Inhibitors Using Machine Learning Method

  Gong, Xiajing; Hu, Meng; Liu, Jinzhong; Zhao, Liang

• Big Data Toolsets to Pharmacometrics: Application of Machine Learning for Time-to-Event Analysis

  Gong, Xiajing; Hu, Meng; Zhao, Liang