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(125)
• Posters(29)
• Presentations(37)
• Papers(59)

• 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

• User Friendly Tools for Population PK and PBPK modeling

  Bies, Robert S

• 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