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)

• Pharmacokinetics and Pharmacogenomics of Bupropion in Three Different Formulations with Different Release Kinetics in Healthy Human Volunteers

  Connarn, Jamie; Flowers, Stephanie; Kelly, Marisa; Luo, Ruijuan; Ward, Kristen; Harrington, Gloria; Moncion, Ila; Kamali, Masoud; Mcinnis, Melivin; Feng, Meihua; Ellingrod, Vicki; Babiskin, Andrew; Zhang, Xinyuan; Sun, Duxin

• 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 E; Schwendeman, Anna; Krishnan, Vishalakshi; Fang, Lanyan; Zhao, Liang

• Validation of a Cage Implant System for Assessing In Vivo Performance of Long-Acting Release Microspheres

  Doty, Amy; Hirota, Keiji; Olsen, Karl; Sakamoto, Naoya; Wang, Yan; Choi, Stephanie; Qu, Wen; Schwemdeman, Anna; Schwendeman, Steven

• Formulation Predictive Dissolution (fPD) Testing to Advance Oral Drug Product Development: An Introduction to the US FDA Funded ’21st Century BA/BE’ Project

  Hens, Bart; Sinko, Patrick; Job, Nicholas; Dean, Meagan; Al Gousous, Jozef; Salehi, Niloufar; Ziff, Robert; Tsume, Yasuhiro; Bermejo, Marival; Paixao, Paulo; Brasseur, James; Yu, Alex; Talattof, Arjang; Benninghoff, Gail; Langguth, Peter; Lennernas, Hans

• Non-Sink Dissolution Behavior and Solubility Limit of Commercial Tacrolimus Amorphous Formulation

  Trasi, Niraj; Purohit, Hitesh; Wen, Hong; Sun, Dajun; Taylor, Lynne

• In Vitro Characterization of the Biomimetic Properties of Poly(dimethylsiloxane) to Simulate Oral Drug Absorption

  Sinko, Patrick; Gidley, David; Vallery, Richard; Lamoureux, Aaron; Amidon, Gordon; Amidon, Gregory

• Biopharmaceutic In Vitro In Vivo Extrapolation (IVIV_E) Informed Physiologically-Based Pharmacokinetic Model of Ritonavir Norvir Tablet Absorption in Humans Under Fasted and Fed State Conditions

  Arora, Sumit; Pansari, Amita; Kilford, Peter; Jamei, Masoud; Gardner, Iain; Turner, David

• Utility of Physiologically Based Absorption Modeling in Implementing Quality by Design in Drug Development

  Zhang, Xinyuan; Lionberger, Robert; Davit, Barbara; Yu, Lawrence

• Using Physiologically Based Pharmacokinetic (PBPK) Modeling to Evaluate the Impact of Pharmaceutical Excipients on Oral Drug Absorption: Sensitivity Analyses

  Chow, Edwin; Talattof, Arjang; Tsakalozou, Eleftheria; Fan, Jianghong; Zhao, Liang; Zhang, Xinyuan

• Risk-Based Bioequivalence Recommendations for Antiepileptic Drugs

  Li, Zhichuan; Fang, Lanyan; Jiang, Wenlei; Kim, Myong Jin; Zhao, Liang