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)

• Measuring the Impact of Gastrointestinal Variables on the Systemic Outcome

  Hens, Bart; Talattof, Arjang; Paixao, Paulo; Bermejo, Marival; Tsume, Yasuhiro; Lobenberg, Raimar; Amidon, Gordon

• Pulse Packet Stochastic Model for Gastric Emptying in the Fasted State: A Physiological Approach

  Amidon, Gordon

• Assessing the Impact of Endogenously Derived Crystalline Drug on the In Vivo Performance of Amorphous Formulations

  Purohit, Hitesh; Trasi, Niraj; Osterling, Donald; Stolarik, Deanne; Jenkins, Gary; Gao, Wenqing; Zhang, Geoff; Taylor, Lynne

• Mechanisms of In Vivo Release of Triamcinolone Acetonide from PLGA Microspheres

  Doty, Amy; Weinstein, David; Hirota, Keiji; Olsen, Karl; Ackermann, Rose; Wang, Yan; Choi, Stephanie; Schwendeman, Steven

• Utility of Physiologically Based Pharmacokinetic Absorption Modeling to Predict the Impact of Salt-to-Base Conversion on Prasugrel HCl Product Bioequivalence in the Presence of Proton Pump Inhibitors

  Fan, Jianghong; Zhang, Xinyuan; Zhao, Liang

• Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches: A Workshop Overview

  Babiskin, Andrew; Wu, Fang; Mousa, Youssef; Tan, Ming Liang; Tsakalozou, Eleftheria; Walenga, Ross; Yoon, Miyoung; Raney, Sam G; Polli, James; Schwendeman, Anna; Krishnan, Vishalakshi; Fang, Lanyan; Zhao, Liang

• 2D NMR Peak Profiling to Compare Chemical Differences between Batches of Pentosan Polysulfate Sodium

  Chen, Kang

• The Impact of Supersaturation Level for Oral Absorption of BCS Class IIb Drugs, Dipyridamole and Ketoconazole, Using in Vivo Predictive Dissolution System: Gastrointestinal Simulator (GIS)

  Tsume, Yasuhiro; Matsui, Kazuki; Searls, Amanda; Takeuchi, Susumu; Amidon, Gregory; Sun, Duxin; Amidon, Gordon

• Mechanistic Fluid Transport Model to Estimate Gastrointestinal Fluid Volume and Its Dynamic Change over Time

  Yu, Alex; Jackson, Trachette; Tsume, Yasuhiro; Koenigsknecht, Mark; Wysocki, Jeffrey; Marciani, Luca; Amidon, Gordon; Frances, Ann; Baker, Jason; Hasler, William; Wen, Bo; Pai, Amit; Sun, Duxin

• The Role of Predictive Biopharmaceutical Modeling and Simulation in Drug Development and Regulatory Evaluation

  Jiang, Wenlei; Kim, Stephanie; Zhang, Xinyuan; Lionberger, Robert; Davit, Barbara; Conner, Dale; Yu, Lawrence