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)

• 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

• In Vitro Dissolution of Fluconazole and Dipyridamole in Gastrointestinal Simulator (GIS), Predicting In Vivo Dissolution and Drug-Drug Interaction Caused by Acid-Reducing Agents

  Matsui, Kazuki; Tsume, Yasuhiro; Amidon, Gregory; Amidon, Gordon

• Physicians’ Trust in the FDA’s Use of Product-Specific Pathways for Generic Drug Approval

  Kesselheim, Aaron; Eddings, Wesley; Raj, Tara; Campbell, Eric; Franklin, Jessica; Ross, Kathryn; Fulchino, Lisa; Avorn, Jerry; Gagne, Joshua

• Population-Based PBPK Model for the Prediction of Time-Variant Bile Salt Disposition within GI Luminal Fluids

  Stamatopoulos, Konstantinos; Pathak, Shriram; Marciani, Luca; Turner, David

• Generic Omeprazole Delayed-Release Capsules: In Vitro Performance Evaluations

  Moore, Terry; Smith, Anjanette; Ye, Wei; Toler, Duckhee; Westenberger, Benjamin; Lionberger, Robert; Raw, Andre; Yu, Lawrence; Buhse, Lucinda

• Evaluation and Optimized Selection of Supersaturating Drug Delivery Systems of Posaconazole (BCS class 2b) in the Gastrointestinal Simulator (GIS): An in Vitro-in Silico-in Vivo Approach

  Hens, Bart; Bermejo, Marival; Tsume, Yasuhiro; Gonzalez Alvarez, Isabel; Ruan, Hao; Matsui, Kazuki; Amidon, Gregory; Cavanagh, Katie; Kuminek, Gislaine; Benninghoff, Gail; Fan, Jianghong; Rodriguez Hornedo, Nair; Amidon, Gordon

• Biopharmaceutical Optimization in Neglected Diseases for Paediatric Patients by Applying the Provisional Paediatric Biopharmaceutical Classification System

  Del Moral Sanchez, Jose; Gonzalez Alvarez, Isabel; Cerda Revert, Aaron; Gonzalez Alvarez, Marta; Revert, Aaron; Navarro Ruiz, Andres; Amidon, Gordon; Bermejo Sanz, Marval