GDUFA Research Outcomes
IR Oral Products
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Global Harmonization of Immediate-Release Solid Oral Drug Product Bioequivalence Recommendations and the Impact on Generic Drug Development
Kotsybar, Joseph; Hakeem, Susan; Zhang, Lei; Jiang, Wenlei; Jhon, Young Kuk
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The Effect of Food Vehicles on In Vitro Performance of Pantoprazole Sodium Delayed Release Sprinkle Formulation
Wu, Kai-Wei; Zheng, Kai; Tian, Li; Xia, Li; Hwang, Sung Yong; Nwakama, Patrick E; Sun, Wei Jhe; Kim, Myong Jin; Tampal, N; Xu, Xiaoming; Boyce, Heather; Feng, Xin
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Development and Validation of a HPLC Method for Dissolution and Stability Assay of Liquid-Filled Cyclosporine Capsule Drug Products
Xu, Xiaoming; Sayeed, Vilayat; Khan, Mansoor
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Development of In Vitro Dissolution Testing Methods to Simulate Fed Conditions for Immediate Release Solid Oral Dosage Forms
Lex, Timothy; Rodriguez, Jason; Zhang, Lei; Jiang, Wenlei; Gao, Zongming
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Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop
Zhang, Xinyuan; Duan, John; Kesisoglou, Filippos; Novakovic, Jasmina; Amidon, Gordon; Jamei, Masoud; Lukacova, Viera; Eissing, Thomas; Tsakalozou, Eleftheria; Zhao, Liang; Lionberger, Robert
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Quantitative Methods and Modeling to Evaluate Alternative Approaches for COVID-19 Interrupted Bioequivalence Studies
Zhao, Liang
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FEV1 Based Bioequivalence Study for Inhaled Corticosteroids
Zhao, Liang
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Use of Modeling and Simulation to Support New BE Approaches
Zhao, Liang
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Intestinal Influx Transporters: A Missing Piece in the Puzzle?
Zhang, Lei
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Physiologically Based Pharmacokinetic Modeling for BCS IV Drugs and Case Examples
Wu, Fang