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.

• All(192)
• Posters(44)
• Presentations(45)
• Papers(103)

• 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

• Hot Melt Extrusion Processing Regimes Based on Temperature-Composition Phase Diagrams

  Taylor, Lynne

• Application of Physiologically-based Pharmacokinetic Absorption Modeling and Simulations for Biopharmaceutics: Risk Assessment and Control of Critical Quality Attributes for Medical Countermeasure Drug Products

  Miao, Lei; Wu, Fang; Moldthan, Huong; Xu, Da; Zhao, Liang; Raines, Kimberly; Seo, Paul