GDUFA Research Outcomes

Data Analytics and 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(101)
• Posters(25)
• Presentations(27)
• Papers(49)

• 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

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

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

• 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

• 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