GDUFA Research Outcomes

BE Methods & 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(251)
• Posters(64)
• Presentations(67)
• Papers(120)

• Low Buffer Capacity and Alternating Motility along the Human Gastrointestinal Tract: Implications for in Vivo Dissolution and Absorption of Ionizable Drugs

  Hens, Bart; Tsume, Yasuhiro; Bermejo, Marival; Paixao, Paulo; Koenigsknecht, Mark; Baker, Jason; Hasler, William; Lionberger, Robert; Fan, Jianghong; Dickens, Joseph; Shedden, Kerby; Wen, Bo; Wysocki, Jeffrey; Loebenberg, Raimar; Lee, Allen; Frances, Ann

• Comparing a Bayesian Approach (BEST) with the Two One Sided Tests (TOST) for Bioequivalence Studies

  Peck, Carl; Campbell, Gregory; Yoo, Isaac; Feng, Kairui; Hu, Meng; Zhao, Liang

• Nanoscale Infrared, Thermal, and Mechanical Characterization of Telaprevir-Polymer Miscibility in Amorphous Solid Dispersions Prepared by Solvent Evaporation

  Taylor, Lynne

• CDER Risk Assessment Exercise to Evaluate Potential Risks from the Use of Nanomaterials in Drug Products

  Cruz, Celia; Tyner, Katherine; Velazquez, Lydia; Hyams, Kenneth; Jacobs, Abigail; Shaw, Arthur; Jiang, Wenlei; Lionberger, Robert; Hinderling, Peter; Kong, Yoon; Brown, Paul; Ghosh, Tapash; Strasinger, Caroline; Suarez Sharp, Sandra; Henry, Don; Uitert, Maat Van; Sadrieh, Nakissa; Morefield, Elaine

• 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

• 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

• Modeling and Simulation of Biopharmaceutical Performance

  Lionberger, Robert

• 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