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)

• Correction to: Outcomes Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence

  Gagne, Joshua; Polinski, Jennifer; Jiang, Wenlei; Dutcher, Sarah; Xie, Jing; Lii, Joyce; Fulchino, Lisa; Kesselheim, Aaron

• Linking the Gastrointestinal Behavior of Ibuprofen with the Systemic Exposure between and within Humans-Part 1: Fasted State Conditions

  Bermejo, Marival; Paixao, Paulo; Hens, Bart; Tsume, Yasuhiro; Koenigsknecht, Mark; Baker, Jason; Hasler, William; Lionberger, Robert; Fan, Jianghong; Dickens, Joseph; Shedden, Kerby; Wen, Bo; Wysocki, Jeffrey; Lobenberg, Raimar; Lee, Allen; Frances, Ann; Amidon, G E; Yu, A; Salehi, N; Talattof, A; Benninghoff, G; Sun, D; Kuminek, G; Cavanagh, K L; Horned, N R; Amidon, G L

• Modeling and Simulation of Biopharmaceutical Performance

  Lionberger, Robert

• Phase Behavior and Crystallization Kinetics of a Poorly Water-Soluble Weakly Basic Drug as a Function of Supersaturation and Media Composition

  Van Duong, Tu; Ni, Zhanglin; Taylor, Lynne

• A Molecular Basis for Innovation in Drug Excipients

  Irwin, John; Pottel, Joshua; Zou, Ling; Wen, Hong; Zuk, Susan; Zhang, Xinyuan; Sterling, Teague; Shoichet, Brian; Lionberger, Robert; Giacomini, Kathleen

• Enhancement of Mass Transfer from Particles by Local Shear-Rate and Correlations with Application to Drug Dissolution

  Brasseur, James

• Vemurafenib: A Tetramorphic System Displaying Concomitant Crystallization from the Supercooled Liquid

  Taylor, Lynne

• The Combination of GIS and Biphasic to Better Predict In Vivo Dissolution of BCS Class IIbDrugs, Ketoconazole and Raloxifene

  Tsume, Yasuhiro; Igawa, Naoto; Drelich, Adam; Amidon, Gregory; Amidon, Gordon

• 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

• The Application of Temperature-Composition Phase Diagrams for Hot Melt Extrusion Processing of Amorphous Solid Dispersions to Prevent Residual Crystallinity

  Taylor, Lynne