GDUFA Research Outcomes
Complex Oral Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the oral route, including buccal and locally-acting gastrointestinal products.
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In Vitro Oral Cavity Permeability Assessment to Enable Simulation of Drug Absorption
Dwivedi, Pankaj; Kalra, Priyata; Zhou, Haiying; Alam, Khondoker; Tsakalozou, Eleftheria; Al-Ghabeish, Manar; Kelchen, Megan; Pauletti, Giovanni
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From In Vitro Dissolution Testing to In Vivo Clinical Pharmacokinetic Prediction Using PBPK Models for Oral Cavity Drug Products
Plait, Fiona; Kalra, Priyata; Le Merdy, Maxime; Subhami, Saima; Lukacova, Viera; Dwivedi, Pankaj; Alam, Khondoker; Tsakalozou, Eleftheria; Pauletti, Giovanni; Zhou, Haiying
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Use of PBBM-PBPK to Predict Mesalamine Delayed-Release Oral Drug Products Performance in Both Healthy and Disease Physiologies
Silva, Daniela; Le Merdy, Maxime; Zhou, Haiying; Fotaki, Nikoletta; Bu, Yingzi; Al-Ghabeish, Manar; Ren, Ping; Wu, Fang
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Review of Complex Generic Drugs Delivered Through the Female Reproductive Tract: The Current Competitive Landscape and Emerging Role of Physiologically Based Pharmacokinetic Modeling to Support Development and Regulatory Decisions
Donnelly, Mark; Tsakalozou, Eleftheria; Sharan, Satish; Straubinger, Thomas; Bies, Robert; Zhao, Liang
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Mechanistic Fluid Transport Model to Estimate Gastrointestinal Fluid Volume and Its Dynamic Change over Time
Yu, Alex; Jackson, Trachette; Tsume, Yasuhiro; Koenigsknecht, Mark; Wysocki, Jeffrey; Marciani, Luca; Amidon, Gordon; Frances, Ann; Baker, Jason; Hasler, William; Wen, Bo; Pai, Amit; Sun, Duxin
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Development and Validation of an Ion Chromatography Method for the Determination of Phosphate-Binding of Lanthanum Carbonate
Samy, Raghu; Faustino, Patrick; Adams, Wallace; Yu, Lawrence; Khan, Mansoor; Yang, Yongsheng
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Measurement of in vivo Gastrointestinal Release and Dissolution of Three Locally Acting Mesalamine Formulations in Regions of the Human Gastrointestinal Tract
Yu, Alex; Baker, Jason; Fioritto, Ann; Wang, Ying; Luo, Ruijuan; Li, Siwei; Wen, Bo; Bly, Michael; Tsume, Yasuhiro; Koenigsknecht, Mark
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Evaluation of the In Vitro Efficacy of Sevelamer Hydrochloride and Sevelamer Carbonate
Yang, Yongsheng; Mohammad, Adil; Berendt, Robert; Carlin, Alan; Khan, Mansoor; Faustino, Patrick
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In Vivo Predictive Dissolution: Comparing the Effect of Bicarbonate and Phosphate Buffer on the Dissolution of Weak Acids and Weak Bases
Krieg, Brian; Taghavi, Seyed; Amidon, Gordon; Amidon, Gregory
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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