GDUFA Research Outcomes
BE Methods and Analyses
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to bioequivalence methods and analyses for generic drug products.
-
Stability of Marketed Tacrolimus Amorphous Dispersions Against Crystallization
Taylor, Lynne
-
A Stochastic Fluid Packet Emptying and Transit Model: A Physiological Approach to Gastrointestinal Transit of Fluid
Amidon, G L
-
Fasted-State Motility-Dependent Gastric Emptying and Plasma Level Variation: Bioequivalence Implications for BCS Class I Drugs
Amidon, G L
-
Evaluation of the Dissolution Drug Release Profiles of Approved Generic Formulations in Multiple pH Media for Putative Biopharmaceutics Classification System Class III Drugs, Atenolol Tablets and Acyclovir Tablets
Selaya, Daniela; Hunt, Robert; Ren, Ping; Li, David; Qu, Haiou; Yang, Wen Cheng; Wang, Jiang; Chan, Theresa; Kim, Myong Jin; Faustino, Patrick; Zhang, Yi
-
Effect Of Crystallinity On The Bioavailability Of Marketed Tacrolimus Amorphous Solid Dispersions
Purohit, Hitesh; Osterling, Donald; Jenkins, Gary; Stolarik, DeAnne; Gao, Wenqing; Gao, Yi; Zhang, Geoff; Taylor, Lynne
-
Limitation In The Pharmacopeial Dissolution Testing Of Marketed Tacrolimus Amorphous Solid Dispersions
Purohit, Hitesh; Gao, Yi; Zhang, Geoff; Sun, Dajun; Wen, Hong; Taylor, Lynne
-
An R-Shiny Application for Design of Comparative Clinical Endpoint Bioequivalence Studies
Park, Wansu; Kim, Myongjin; Zhao, Liang; Fang, Lanyan
-
Influence Of Fluid Shear Rate On The Dissolution Rate Of Poorly Soluble Drug Particles; Implications For In Vivo Predictive In Vitro Dissolution Methodologies And Mechanistic Computational Modeling.
Mudie, Deanna; Brasseur, James; Mansfield, Joel; Wang, Yanxing; Jayaraman, Balaji; Amidon, Gregory
-
The Application of Temperature-Composition Phase Diagrams for Hot Melt Extrusion Processing of Amorphous Solid Dispersions to Prevent Residual Crystallinity
Taylor, Lynne
-
Exploiting Melting Point Depression for Hot Melt Extrusion Processing of Amorphous Solid Dispersions
Taylor, Lynne