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)

• Machine Learning For Adverse Drug Event Detection

  Page, David

• Complex Drug Product Landscape

  Jiang, Wenlei

• Post-marketing Surveillance of Generic Drug Usage and Substitution Patterns

  Jiang, Wenlei

• Challenges in Processing PK Data from ANDA Submissions for BE Assessment and Current Perspectives on Updating the PK Data Standard

  Hu, Meng

• Dose Scale Analysis to Support Bioequivalence Assessment

  Hu, Meng

• Use of Data Analytics Approaches to Support Regulatory Assessment – from FDA Perspective

  Hu, Meng

• Leveraging Artificial Intelligence (AI) and Machine Learning (ML) to Support Generic Drug Development and Regulatory Efficiency

  Hu, Meng

• Utility of Artificial Intelligence to Facilitate the Development and Regulatory Assessment of Complex Generic Drugs

  Hu, Meng

• Leveraging Artificial Intelligence (AI) and Machine Learning (ML) to Support Regulatory Efficiency – Current Progress

  Hu, Meng

• Development of a Data/Text Analytics Tool to Enhance Quality and Efficiency of Bioequivalence Assessment

  Hu, Meng