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)

• A Molecular Basis for Innovation in Drug Excipients

  Irwin, John; Pottel, Joshua; Zou, Ling; Wen, Hong; Zuk, Susan; Zhang, Xinyuan; Sterling, Teague; Shoichet, Brian; Lionberger, Robert; Giacomini, Kathleen

• Association between Higher Generic Drug Use and Medicare Part D Star Ratings: An Observational Analysis

  Hohmann, Natalie; Hansen, Richard; Garza, Kimberly; Harris, Ilene; Kiptanui, Zippora; Qian, Jingjing

• Erratum to: Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products

  Chang, Rong-Kun; Raw, Andre; Lionberger, Robert; Yu, Lawrence

• Variations in Patients’ Perceptions and Use of Generic Drugs: Results of a National Survey

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

• Improved GSimp: A Flexible Missing Value Imputation Method to Support Regulatory Bioequivalence Assessment

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

• Model-Based Approach for Optimizing Study Design and Clinical Drug Performances of Extended-Release Formulations of Methylphenidate for the Treatment of Attention-Deficit Hyperactivity Disorder

  Gomeni, Roberto; Lucy, Fang; Bressolle Gomeni, Fran̤oise; Spencer, Thomas; Faraone, Stephen; Babiskin, Andrew

• Evaluation of Switching Patterns in FDA’s Sentinel System: A New Tool to Assess Generic Drugs

  Gagne, Joshua; Popovic, Jennifer; Nguyen, Michael; Sandhu, Sukhminder; Greene, Patty; Izem, Rima; Jiang, Wenlei; Wang, Zhong; Zhao, Yueqin; Petrone, Andrew; Wagner, Anita; Dutcher, Sarah

• Equivalence Testing of Complex Particle Size Distribution Profiles Based on Earth Mover’s Distance

  Hu, Meng; Jiang, Xiaohui; Absar, Mohammad; Choi, Stephanie; Kozak, Darby; Shen, Meiyu; Weng, Yuting; Zhao, Liang; Lionberger, Robert

• Decoding Kinase-Adverse Event Associations for Small Molecule Kinase Inhibitors

  Gong, Xiajing; Hu, Meng; Liu, Jinzhong; Kim, Geoffrey; Xu, James; Mckee, Amy; Palmby, Todd; Claro, R Angelo De; Zhao, Liang

• Determinants Of Generic Drug Substitution In The United States

  Segal, Jodi; Onasanya, Oluwadamilola; Daubresse, Matthew; Lee, Chia Ying; Moechtar, Mischka; Pu, Xia; Dutcher, Sarah; Romanelli, Robert