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)

• 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

• An Open Access Excipients Database and Its Use to Investigate Their Possible Biological Targets

  Shoichet, B

• Changing Physician and Patient Perceptions about Generic Drugs

  Sarpatwari, Ameet

• Performance of Machine Learning Algorithms for Model Selection

  Sale, Mark

• Provider-Level Variation And Determinants Of Outpatient Generic Prescribing In A Mixed-Payer Healthcare System

  Romanelli, Robert; Nimbal, Vani; Segal, Jodi

• Activity Of Inactive Ingredients: Foundations For Innovation In Drug Excipients

  Pottel, Josh; Algaa, Enkhjargal; Irwin, John; Shoichet, Brian