GDUFA Research Outcomes
BE Methods & Analyses
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Assessment on the Formulation Similarity of Approved Generic Drug Products and their Respective Reference Products Which are Considered as Potential BCS Class 3 Drugs
Chan, Theresa; Ren, Ping; Yang, Wen Cheng; Wang, Yan; Luke, Markham; Kim, Myong Jin; Zhang, Yi
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In Vitro Comparative Dissolution and Permeation Testing Using the In-vitro Dissolution Absorption System (IDAS) for Expanding Biowaivers to Non Q1/Q2 BCS Class III Products
Bode, Chris; Bhoopathy, Sid; Miezeiewski, Blair; Wu, Fang; Ren, Ping; Wang, Zhong; Zhao, Liang
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Using the In-vitro Dissolution Absorption System (IDAS) to Evaluate the Effects of Excipients on the Permeation of Putative Biopharmaceutics Classification System Class III Drugs
Bode, Chris; Bhoopathy, Sid; Miezeiewski, Blair; Wu, Fang; Ren, Ping; Wang, Zhong; Zhao, Liang
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The Interplay Between Pharmaceutical Dissolution and Absorption in the Human Gut Studied with Computer Simulation
Behafarid, F; Vijayakumar, G; Brasseur, J G
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Assessing the Bioequivalence of Tacrolimus Amorphous Formulations with Varying Degrees of Crystallinity using Mechanistic Dissolution Models in a Population Physiologically-based Pharmacokinetic (PBPK) Modelling Framework
Arora, Sumit; Patel, Nikunjkumar; Jamei, Masoud; Turner, David
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Fasted State Motility-Dependent Transit And Dissolution Of Ibuprofen.
Amidon, G L
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Assessing the Impact of Excipient and Food Intake on Bioequivalence Using PBPK and Virtual Bioequivalence Trial: A Case Example with Acyclovir Immediate Release Tablets
Al Shoyaib, Abdullah; Fang, Lanyan; Zhao, Liang; Wu, Fang