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)

• Increasing Impact of Quantitative Methods and Modeling in Establishment of Bioequivalence and Characterization of Drug Delivery

  Yoon, Miyoung; Babiskin, Andrew; Hu, Meng; Wu, Fang; Raney, Sam G.; Fang, Lanyan; Zhao, Liang

• 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

• Leveraging GPT-4 for Food Effect Summarization to Enhance Product-Specific Guidance Development via Iterative Prompting

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

• Switch-Backs 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

• Estimating Generic Drug Use with Electronic Health Records Data from a Health Care Delivery System: Implications for Quality Improvement Research

  Nimbal, Vani; Segal, Jodi; Romanelli, Robert

• The Association between Patient Sociodemographic Characteristics and Generic Drug Use: A Systematic Review and Meta-Analysis

  Mishuk, Ahmed; Qian, Jingjing; Howard, Jennifer; Harris, Ilene; Frank, Gavriella; Kiptanui, Zippora; Hansen, Richard

• A General Framework for Assessing IVIVC as a Tool for Maximizing the Benefit-Risk Ratio of a Treatment Using a Convolution-Based Modeling Approach

  Gomeni, Roberto; Fang, Lanyan; Gomeni, Francoise; Spencer, Thomas; Faraone, Stephen; Babiskin, Andrew

• Brand vs Generic Adverse Event Reporting Patterns: An Authorized Generic-Controlled Evaluation of Cardiovascular Medications

  Alatawi, Yasser; Rahman, Mmd Motiur; Cheng, Ning; Qian, Jingjing; Peissig, Peggy; Berg, Richard; Page, David; Hansen, Richard

• Generic Development of Topical Dermatologic Products, Part II: Quality by Design for Topical Semisolid Products

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

• Considerations for Generic-to-Generic Levothyroxine Switching-Reply

  Brito, Juan P; Wang, Zhong; Lipska, Kasia