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)

• Outcomes Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence

  Gagne, Joshua; Polinski, Jennifer; Jiang, Wenlei; Dutcher, Sarah; Xie, Jing; Lii, Joyce; Fulchino, Lisa; Kesselheim, Aaron

• Comment on: ���Mixed Approach Retrospective Analyses of��Suicide and��Suicidal Ideation for��Brand Compared with��Generic Central Nervous System Drugs�۝

  Suggs, Courtney; Levin, Robert; Mosholder, Andrew; Swain, Richard; Zhao, Liang

• Role of Authorized Generics in Postapproval Surveillance of Generic Drug Products

  Gagne, Joshua; Sarpatwari, Ameet; Desai, Rishi

• Improving Imbalanced Learning by Pre-finetuning with Data Augment

  Shi, Yiwen; Valizadehaslani, Taha; Wang, Jing; Ren, Ping; Zhang, Yi; Hu, Meng; Zhao, Liang; Liang, Hualou

• Quantification of Monomer Units in Insoluble Polymeric Active Pharmaceutical Ingredients Using Solid-State NMR Spectroscopy I: Patiromer

  Jarrells, Travis; Zhang, Deyi; Li, Shaohua; Munson, Eric

• Information Extraction From FDA Drug Labeling to Enhance Product-Specific Guidance Assessment Using Natural Language Processing

  Shi, Yiwen; Ren, Ping; Zhang, Yi; Gong, Xiajing; Hu, Meng; Liang, Hualou

• Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products

  Chang, Rong-Kun; Raw, Andre; Lionberger, Robert; Yu, Lawrence

• Predictive Analysis of First Abbreviated New Drug Application Submission for New Chemical Entities Based on Machine Learning Methodology

  Hu, Meng; Babiskin, Andrew; Wittayanukorn, Saranrat; Schick, Andreas; Rosenberg, Matthew; Gong, Xiajing; Kim, Myongjin; Zhang, Lei; Lionberger, Robert; Zhao, Liang

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

  Gong, Xiajing; Hu, Meng; Zhao, Liang

• Association Between Generic-to-Generic Levothyroxine Switching and Thyrotropin Levels Among US Adults

  Brito, Juan P; Deng, Yihong; Ross, Joseph S; Choi, Nam Hee; Graham, David J; Qiang, Yandong; Rantou, Eleni; Wang, Zhong; Zhao, Liang; Shah, Nilay D; Lipska, Kasia J