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(120)
• Posters(29)
• Presentations(34)
• Papers(57)

• 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

• Physicians’ Trust in the FDA’s Use of Product-Specific Pathways for Generic Drug Approval

  Kesselheim, Aaron; Eddings, Wesley; Raj, Tara; Campbell, Eric; Franklin, Jessica; Ross, Kathryn; Fulchino, Lisa; Avorn, Jerry; Gagne, Joshua

• Comparative Effectiveness of Generic and Brand-Name Medication Use: A Database Study of US Health Insurance Claims

  Desai, Rishi; Sarpatwari, Ameet; Dejene, Sara; Khan, Nazleen; Lii, Joyce; Rogers, James; Dutcher, Sarah; Raofi, Saeid; Bohn, Justin; Connolly, John; Fischer, Michael; Kesselheim, Aaron; Gagne, Joshua

• Heterogeneous Treatment Effect Analysis Based on Machine-Learning Methodology

  Gong, Xiajing; Hu, Meng; Basu, Mahashweta; Zhao, Liang

• The activities of drug inactive ingredients on biological targets

  Pottel, Joshua; Armstrong, Duncan; Zou, Ling; Fekete, Alexander; Huang, Xiping; Torosyan, Hayarpi; Bednarczyk, Dallas; Whitebread, Steven; Bhhatarai, Barun; Liang, Guiqing; Jin, Hong; Ghaemi, Nassir; Slocum, Samuel; Lukacs, Katalin; Irwin, John; Berg, Ell

• Fine-Tuning BERT for Automatic ADME Semantic Labeling in FDA Drug Labeling to Enhance Product-Specific Guidance Assessment

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