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)

• 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

• 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

• Spreadability Measurements to Assess Structural Equivalence (Q3) of Topical Formulations–a Technical Note

  Kryscio, David; Sathe, Pradeep; Lionberger, Robert; Yu, Lawrence; Bell, Michael; Jay, Michael; Hilt, Zach

• Identification of Non-Reported Bupropion Metabolites in Human Plasma

  Connarn, Jamie; Luo, Ruijuan; Windak, Jim; Zhang, Xinyuan; Babiskin, Andrew; Kelly, Marisa; Harrington, Gloria; Ellingrod, Vicki; Kamali, Masoud; Mcinnis, Melvin; Sun, Duxin

• Impact of Polymers on the Melt Crystal Growth Rate of Indomethacin Polymorphs

  Tian, Bin; Gao, Wei; Tao, Xiaoguang; Tang, Xing; Taylor, Lynne

• The Influence Of Formulation Variables On The Performance Of A Beclomethasone Dipropionate Metered Dose Inhaler

  Holt, Jay; Sandell, Dennis; Hickey, Anthony; Vallorz, Ernest; Straughn, Kevin