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)

• 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

• 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

• 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

• 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

• 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