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)

• pyDarwin Machine Learning Algorithms Application and Comparison in Nonlinear Mixed-effect Model Selection and Optimization

  Li, Xinnong; Sale, Mark; Nieforth, Keith; Craig, James; Wang, Fenggong; Solit, David; Feng, Kairui; Hu, Meng; Bies, Robert; Zhao, Liang

• pyDarwin: A Machine Learning Enhanced Automated Nonlinear Mixed-Effect Model Selection Toolbox

  Li, Xinnong; Sale, Mark; Nieforth, Keith; Bigos, Kristin L; Craig, James; Wang, Fenggong; Feng, Kairui; Hu, Meng; Bies, Robert; Zhao, Liang

• Development of Quantitative Comparative Approaches to Support Complex Generic Drug Development

  Gong, Yuqing; Barretto, Francis Xavier; Tsong, Yi; Mousa, Youssef; Ren, Ke; Kozak, Darby; Shen, Meiyu; Hu, Meng; Zhao, Liang

• Product Quality Research for Developing and Assessing Regulatory Submissions for Generic Cyclosporine Ophthalmic Emulsions

  Belenos, Avery; Wood, Erin; Hu, Meng; Kozak, Darby; Xu, Xiaoming; Fisher, Adam

• PharmBERT: A Domain-specific BERT Model for Drug Labels

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

• 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