GDUFA Research Outcomes
OA Models
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to computational modeling of absorption for orally administered drugs to support generic product development and assessment.
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Prediction of In Vitro Drug Dissolution into Fasted-State Biorelevant Media: Contributions of Solubility Enhancement and Relatively Low Colloid Diffusivity
Polli, James E.
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Application of Solubility and Dissolution Profile Comparison for Prediction of Gastric pH-Mediated Drug-Drug Interactions
Miao, Lei; Wu, Fang; Yang, Xinning; Mousa, Youssef; Ramamoorthy, Anuradha; Lee, Sue-Chih; Raines, Kimberly; Zhang, Lei; Seo, Paul
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Development of Best Practices in Physiologically Based Pharmacokinetic Modeling to Support Clinical Pharmacology Regulatory Decision-making—A Workshop Summary
Jean, Daphney; Naik, Kunal; Milligan, Lauren; Hall, Stephen; Huang, Shiew Mei; Isoherranen, Nina; Kuemmel, Colleen; Seo, Paul; Tegenge, Million; Wang, Yaning; Yang, Yuching; Zhang, Xinyuan; Zhao, Liang; Zhao, Ping; Benjamin, Jessica; Bergman, Kimberly; Grillo, Joseph; Madabushi, Rajanikanth; Wu, Fang; Zhu, Hao; Zineh, Issam
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Application of Physiologically-Based Pharmacokinetic Modeling to Predict Gastric pH-Dependent Drug-Drug Interactions for Weak Base Drugs
Dong, Zhongqi; Li, Jia; Wu, Fang; Zhao, Ping; Lee, Sue-Chih; Zhang, Lillian; Seo, Paul; Zhang, Lei
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Exploring the Relationship of Drug BCS Classification, Food Effect, and Gastric pH-Dependent Drug Interactions
Owens, Katie; Argon, Sophie; Yu, Jingjing; Yang, Xinning; Wu, Fang; Lee, Sue-Chih; Sun, Wei-Jhe; Ramamoorthy, Anuradha; Zhang, Lei; Ragueneau-Majlessi, Isabelle
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Prediction of In Vitro Drug Dissolution into Fed-state Biorelevant Media: Contributions of Solubility Enhancement and Relatively Low Colloid Diffusivity
Polli, James E.
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Prediction of Food Effect on In Vitro Drug Dissolution into Biorelevant Media: Contributions of Solubility Enhancement and Relatively Low Colloid Diffusivity
Polli, James E.
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Effect of Oral Ranitidine on Urinary Excretion of N-Nitrosodimethylamine (NDMA)
Florian, Jeffry; Matta, Murali; Depalma, Ryan; Gershuny, Victoria; Patel, Vikram; Hsiao, Cheng-Hui; Zusterzeel, Robbert; Rouse, Rodney; Prentice, Kristin; Nalepinski, Colleen Gosa; Kim, Insook; Yi, Sojeong; Zhao, Liang; Yoon, Miyoung; Selaya, Susan; Keire, David; Korvick, Joyce
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Research and Education Needs for Complex Generics
Stern, Sydney; Coghlin, Jill; Krishnan, Vishalakshi; Raney, Sam G; Babiskin, Andrew; Jiang, Wenlei; Lionberger, Robert; Xu, Xiaoming; Schwendeman, Anna; Polli, James E.