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)

• 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

• Dissolution and Translational Modeling Strategies Toward Establishing an In Vitro-In Vivo Link-a Workshop Summary Report

  Heimbach, Tycho; Suarez Sharp, Sandra; Kakhi, Maziar; Holmstock, Nico; Olivares Morales, Andres; Pepin, Xavier; Sjogren, Erik; Tsakalozou, Eleftheria; Seo, Paul; Li, Min; Zhang, Xinyuan; Lin, Hopi; Montague, Timothy; Mitra, Amitava; Morris, Denise; Patel, N; Kesisoglou, F

• Dissolution Performance of Binary Amorphous Drug Combinations–Impact of a Second Drug on the Maximum Achievable Supersaturation

  Taylor, Lynne

• Modeling and Simulation of the Effect of Proton Pump Inhibitors on Magnesium Homeostasis. 1. Oral Absorption of Magnesium

  Bai, Jane; Hausman, Ethan; Lionberger, Robert; Zhang, Xinyuan

• The activities of drug inactive ingredients on biological targets

  Pottel, Joshua; Armstrong, Duncan; Zou, Ling; Fekete, Alexander; Huang, Xiping; Torosyan, Hayarpi; Bednarczyk, Dallas; Whitebread, Steven; Bhhatarai, Barun; Liang, Guiqing; Jin, Hong; Ghaemi, Nassir; Slocum, Samuel; Lukacs, Katalin; Irwin, John; Berg, Ell