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)

• Quantitative Methods for Determining Equivalence of Particle Size Distributions

  Hu, Meng

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

  Hu, Meng

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

  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

• Alternatives to f2 Testing for Dissolution Similarity – f2 Bootstrapping and Multivariate Statistical Distance (MSD) Method

  Gong, Xiajing

• IVPT Data Challenges and Statistical Analysis

  Ghosh, Priyanka

• Use of Regulatory Science Research to Support post-Marketing Surveillance of Generic Drug Products

  Dutcher, Sarah

• Predictors of Generic Thyroid Hormone Utilization among the Commercially Insured

  Daubresse, Matthew

• Association of Authorized Generic Marketing with Prescription Drug Spending on Antidepressants from 2000 to 2011

  Cheng, Ning; Banerjee, Tannista; Qian, Jingjing; Hansen, Richard