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)

• Utilization of Gastrointestinal Simulator, an in Vivo Predictive Dissolution Methodology, Coupled with Computational Approach to Forecast Oral Absorption of Dipyridamole

  Matsui, Kazuki; Tsume, Yasuhiro; Takeuchi, Susumu; Searls, Amanda; Amidon, Gordon

• Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop

  Zhang, Xinyuan; Duan, John; Kesisoglou, Filippos; Novakovic, Jasmina; Amidon, Gordon; Jamei, Masoud; Lukacova, Viera; Eissing, Thomas; Tsakalozou, Eleftheria; Zhao, Liang; Lionberger, Robert

• Investigating the Correlation between Miscibility and Physical Stability of Amorphous Solid Dispersions Using Fluorescence-Based Techniques

  Tian, Bin; Tang, Xing; Taylor, Lynne

• Using a Physiologically Based Pharmacokinetic Absorption Model to Establish Dissolution Bioequivalence Safe Space for Oseltamivir in Adult and Pediatric Populations

  Miao, Lei; Mousa, Youssef; Zhao, Liang; Raines, Kimberly; Seo, Paul; Wu, Fang

• Quantitative Methods and Modeling to Assess COVID-19 Interrupted In Vivo Pharmacokinetic Bioequivalence Studies with Two Reference Batches

  Gong, Yuqing; Feng, Kairui; Zhang, Peijue; Lee, Jieon; Pan, Yuzhuo; Zhang, Zhen; Ni, Zhanglin; Bai, Tao; Yoon, Miyoung; Li, Bing; Kim, Carol Y; Fang, Lanyan; Zhao, Liang

• Novel and Rapid LC-MS/MS Method for Quantitative Analysis of Methylphenidate in Dried Blood Spots

  Gandhi, Adarsh; Beekman, Christopher; Parker, Robert; Fang, Lanyan; Babiskin, Andrew; Matta, Murali

• 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