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)

• Differences in Rates of Switchbacks after Switching from Branded to Authorized Generic and Branded to Generic Drug Products: Cohort Study

  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

• Evaluation of Socioeconomic Status Indicators for Confounding Adjustment in Observational Studies of Medication Use

  Gopalakrishnan, Chandrasekar; Gagne, Joshua; Sarpatwari, Ameet; Dejene, Sara; Dutcher, Sarah; Levin, Raisa; Franklin, Jessica; Scheeweiss, Sebastian; Desai, Rishi

• Predicting Future Generic Drug Competition: Powering Strategic Planning Using Quantitative Methods and Modeling

  Zhao, Liang

• Big Data Application in Life Sciences

  Zhao, Liang

• FDA Scientific Efforts on Investigating Excipient-Drug Interactions

  Zhang, Lei

• Regulatory Science Issues in the Effect of Microbimes on Bioequivalence Determination for Generic Drug Products

  Zhang, Lei

• Developing a Statistical Approach to Facilitate Sameness Assessment of Complex Heterogenous Active Pharmaceutical Ingredients

  Weng, Yu Ting; Hu, Meng; Zhao, Liang; Wang, Chao; Shen, Meiyu; Gong, Xiajing

• Leveraging Large Language Models (LLMs) to Support Regulatory Assessments

  Wang, Jing

• Approaches to Analyzing Comparative Use Human Factors Studies

  Wang, Jing

• Advance in Data Imputation Approach to Support BE Assessment

  Wang, Jing