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)

• 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

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

  Hu, Meng

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

  Hu, Meng

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

  Hu, Meng

• Quantitative Methods for Determining Equivalence of Particle Size Distributions

  Hu, Meng

• Big Data Toolsets to Pharmacometrics: Application of Machine Learning for Time-to-Event Analysis

  Hu, Meng

• Equivalence Testing of Complex Particle Size Distribution Profiles Based on Earth Mover’s Distance

  Hu, Meng

• Predictive Analysis of First ANDA Submission for NCEs Based on Machine Learning Methodology

  Hu, Meng

• Prediction of the First ANDA Submission for NCEs Utilizing Machine Learning Methodology

  Hu, Meng