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)

• Predictive Analysis for First Submission of Generic Drug Application for Orphan Drug Products Using Random Survival Forest

  Hopefl, Robert; Wang, Jing; Mohan, Abhinav Ram; Sun, Wei-Jhe; Kim, Myong-Jin; Hu, Meng; Fang, Lanyan

• Raman Spectroscopy as a Tool to Accelerate Development of Complex Medicinal Products

  Zarmpi, Panagiota; Tsikritsis, Dimitrios; Watson, Andrew C; Vorng, Jean-Luc; Tyagi, Vasundhara; Belsey, Natalie A; Rantou, Elena; Ghosh, Priyanka; Bunge, Annette L; Woodman, Timothy J; Delgado-Charro, M Begona; Guy, Richard H

• The Future of AI and the Generic Drug Community

  Lionberger, Robert

• Leveraging Generative AI (GenAI) to Support Regulatory Assessment

  Hu, Meng

• Generative AI-Powered Regulatory Efficiency and Excellence

  Lee, Jae

• 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