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)

• 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

• Advance in Data Imputation Approach to Support BE Assessment

  Wang, Jing

• 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

• Heterogeneous Treatment Effect Analysis Based on Machine Learning Methodology

  Hu, M

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

  Zuckerman, Ilene; Pradel, Francoise; Palumbo, Francis; Shen, Xian; Kiptanui, Zippora; Polli, James; Gardner, Jim; Franey, Christine; Malik, Sana

• Product-Specific Guidances for New Chemical Entity (NCE) Drug Products

  Wittayanukorn, Saranrat; Dutcher, Sarah; Zhao, Liang; Babiskin, Andrew

• Improved GSimp – a Flexible Missing Value Imputation Method to Support Generic Drug Development and Regulatory Assessment

  Wang, J; Gong, X; Zhao, L; Hu, M