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)

• The Global Bioequivalence Harmonisation Initiative (GBHI): Report of the European Federation of Pharmaceutical Sciences (EUFEPS)/the Amercian Association of Pharmaceutical Scientists (AAPS) fourth conference

  Blume, Hh; Mehta, M; Beuerle, G; Dorantes, A; Hempel, G; Jiang, W; Kovar, A; Lee, J; Potthast, H; Schug, B; Seidlitz, A; Tampal, N; Tsang, Y-C; Walstab, J; Welink, J

• In Vivo Predictive Dissolution and Simulation Workshop Report: Facilitating the Development of Oral Drug Formulation and the Prediction of Oral Bioperformance

  Tsume, Yasuhiro; Patel, Sanjaykumar; Fotaki, Nikoletta; Bergstrom, Christel; Amidon, Gordon; Brasseur, James; Mudi, Deanna; Sun, Duxin; Bermejo, Marival; Gao, Ping; Zhu, Wei; Sperry, David; Vertzoni, Maria; Parrott, Neil; Lionberger, Robert; Kambayashi, A

• Impact of Pharmaceutical Excipients on Oral Drug Absorption: A Focus on Intestinal Drug Transporters

  Zou, Ling; Ni, Zhanglin; Tsakalozou, Eleftheria; Giacomini, Kathleen

• A Critical Overview of the Biological Effects of Excipients (Part II): Scientific Considerations and Tools for Oral Product Development: Scientific Considerations and Tools for Product Development

  Martinez, M; Wu, Fang; Sinko, B; Brayden, D J; Grass, M; Kesisoglou, F; Stewart, A; Sugano, K

• Interaction of Commonly Used Oral Molecular Excipients with P-glycoprotein

  Bajaj, Ruchika; Chong, Lisa; Zou, Ling; Tsakalozou, Eleftheria; Ni, Zhanglin; Giacomini, Kathleen; Kroetz, Deanna

• In Vitro Dissolution Methodology, Mini-Gastrointestinal Simulator (mGIS), Predicts Better in Vivo Dissolution of a Weak Base Drug, Dasatinib

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

• Unmet Needs: Research Helps Regulators do Their Jobs

  Altman, Russ; Khuri, Natalia; Salit, Marc; Giacomini, Kathleen

• Metabolism of Bupropion by Carbonyl Reductases in Liver and Intestine

  Connarn, Jamie; Zhang, Xinyuan; Babiskin, Andrew; Sun, Duxin

• Development of a Pediatric Relative Bioavailability/Bioequivalence Database and Identification of Putative Risk Factors Associated With Evaluation of Pediatric Oral Products

  Pawar, Gopal; Wu, Fang; Zhao, Liang; Fang, Lanyan; Burckart, Gilbert; Feng, Kairui; Mousa, Youssef; Naumann, Franci; Batchelor, Hannah

• Pharmaceutical Aerosols Deposition Patterns from a Dry Powder Inhaler: Euler Lagrangian Prediction and Validation

  Kannan, Ravishekar; Chen, Zhijian; Singh, Narender; Przekwas, Andrzej; Delvadia, Renishkumar; Tian, Geng; Walenga, Ross