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)

• Physicians’ Trust in the FDA’s Use of Product-Specific Pathways for Generic Drug Approval

  Kesselheim, Aaron; Eddings, Wesley; Raj, Tara; Campbell, Eric; Franklin, Jessica; Ross, Kathryn; Fulchino, Lisa; Avorn, Jerry; Gagne, Joshua

• Comparative Effectiveness of Generic and Brand-Name Medication Use: A Database Study of US Health Insurance Claims

  Desai, Rishi; Sarpatwari, Ameet; Dejene, Sara; Khan, Nazleen; Lii, Joyce; Rogers, James; Dutcher, Sarah; Raofi, Saeid; Bohn, Justin; Connolly, John; Fischer, Michael; Kesselheim, Aaron; Gagne, Joshua

• Heterogeneous Treatment Effect Analysis Based on Machine-Learning Methodology

  Gong, Xiajing; Hu, Meng; Basu, Mahashweta; Zhao, Liang

• The activities of drug inactive ingredients on biological targets

  Pottel, Joshua; Armstrong, Duncan; Zou, Ling; Fekete, Alexander; Huang, Xiping; Torosyan, Hayarpi; Bednarczyk, Dallas; Whitebread, Steven; Bhhatarai, Barun; Liang, Guiqing; Jin, Hong; Ghaemi, Nassir; Slocum, Samuel; Lukacs, Katalin; Irwin, John; Berg, Ell

• Fine-Tuning BERT for Automatic ADME Semantic Labeling in FDA Drug Labeling to Enhance Product-Specific Guidance Assessment

  Shi, Yiwen; Wang, Jing; Ren, Ping; Valizadehaslani, Taha; Zhang, Yi; Hu, Meng; Liang, Hualou

• Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs

  Cheng, Ning; Rahman, Motiur; Alatawi, Yasser; Qian, Jingjing; Peissig, Peggy; Berg, Richard; Page, David; Hansen, Richard

• Comparison Of Outcomes Following A Switch From A Brand To An Authorized Vs. Independent Generic Drug

  Hansen, Richard; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane-Vazquez, Enrique; Enrique; Dutcher, Sarah; Raofi, Saeid; Page, David; Peissig, Peggy

• Medication Cost-Savings and Utilization of Generic Inhaled Corticosteroid (ICS) and Long-Acting Beta-Agonist (LABA) Drug Products in the USA

  Wang, Zhong; Ahluwalia, Sharon; Newman, Bryan; Dhapare, Sneha; Zhao, Liang; Luke, Markham

• Correction to: Outcomes Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence

  Gagne, Joshua; Polinski, Jennifer; Jiang, Wenlei; Dutcher, Sarah; Xie, Jing; Lii, Joyce; Fulchino, Lisa; Kesselheim, Aaron

• Random-Effects Linear Modeling and Sample Size Tables for Two Special Cross-over Designs of Average Bioequivalence Studies: the 4-Period, 2-Sequence, 2 Formulation and 6-Period, 3-Sequence, 3-Formulation Designs

  Diaz, Francisco; Berg, Michael; Krebill, Ron; Welty, Timothy; Gidal, Barry; Alloway, Rita; Privitera, Michael