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)

• 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

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

  Wang, Jing; Gong, Xiajing; Zhao, Liang; Hu, Meng

• Searchable Database of FDA Product-specific Recommendations Used to Establish Therapeutic Equivalence of Generic Drug Products

  Tsakalozou, Eleftheria; Hu, Meng; Zhang, Xinyuan; Babiskin, Andrew; Zhao, Liang; Jiang, Wenlei

• Exploring Factors Affecting Nifedipine Biphasic Dissolution Profile Using an inForm Platform

  Tian, Li; Box, Karl; Swoboda, Moriah; Tang, Fuxing; Lin, Ho-Pi; Jiang, Wenlei; Ruzicka, Connie; Rodriguez, Jason; Gao, Zongming

• Determinants Of Generic Drug Substitution In The United States

  Segal, Jodi; Daubresse, Matthew; Onasanya, Olukayode

• Therapeutic Class Differences In Generic Usage

  Segal, Jodi; Daubresse, Matthew; Lee, Chiaying; Dutcher, Sarah; Jiang, Wenlei; Moechtar, Mischka; Romanelli, Robert

• Comparison of Robustness and Efficiency of Four Machine Learning Algorithms for Identification of Optimal Population Pharmacokinetic Models

  Sale, Mark; Ismail, Mohamed; Wang, Fenggong; Feng, Kairui; Hu, Meng; Zhao, Liang; Bies, Robert