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)

• Assessment of Bio(in)equivalence of Metronidazole Topical Formulation using Stimulated Raman Scattering Microscopy

  Zarmpi, P; Tsikritsis, D; Watson, A; Vorng, J L; Tyagi, V; Ghosh, P; Belsey, N; Woodman, T J; Jane White, KA; Bunge, A L; Delgado-Charro, M; Guy, R H

• Application of Quantitative Models to Systematically Evaluate Factors Impacting Swallowability of Tablets

  Cui, Di; Li, Karen; Al Ghabeish, Manar; Mcguire, Meredith; Sun, Wei-Jhe; Hu, Meng; Zhao, Liang; Kim, Myong – Jin

• Performance of Machine Learning Algorithms for Model Selection

  Li, Xinnong; Sale, Mark; Nieforth, Keith; Craig, James; Wang, Fenggong; Solit, David; Feng, Kairui; Hu, Meng; Bies, Robert; Zhao, Liang

• AI-Assisted Tool to Improve the Quality and Assessment of PLGA Formulations

  Das, Jayanti; Hasan, Md Easin; Smith, William; Graner, John; Qin, Bin; Wang, Yan; Park, Kinam; Tian, Geng; Xu, Xiaoming

• 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