GDUFA Research Outcomes
Complex Oral Products
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Contrasting Regional Availability Of Different Mesalamine Products In The Gastrointestinal Tract In Healthy Humans Using A Novel Multi-Port Luminal Aspiration System And Correlation With Systemic Absorption.
Fioritto, Ann; Baker, Jason; Collins, Kristen; Wen, Bo; Wang, Ying; Luo, Ruijuan; Bleske, Barry; Johnson, Mark; Koenigsknecht, Mark; Hasler, William; Sun, Duxin
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Development of an in-Vitro Protein Binding Method for the Evaluation of Bioequivalence of Sucralfate Suspension
Feng, Xin; Al-Ghabeish, Manar; Lionberger, Robert; Cruz, Celia; Ashraf, Muhammad
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A Novel Method To Investigate Local Concentrations Of Mesalamine In The Gastrointestinal Tract Of Healthy Volunteers.
Brown, Sara; Bly, Michael; Baker, Jason; May, Kristen; Fioritto, Ann; Hasler, William; Sun, Duxin
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In Vitro Evaluation of the Performance of a Locally-acting Gastrointestinal Drug, Sucralfate
Al-Ghabeish, Manar; Manar; Feng, Xin; Mohammad, Adil; Lionberger, Robert; Robert; Faustino, Patrick; Ashraf, Muhammad