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)

• Using a Physiologically-based Pharmacokinetic Absorption Model to Establish Clinically Relevant Dissolution Safe Space for Oseltamivir in Adult and Pediatrics

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

• Fasted and Fed Motility of the Undisturbed Small Bowel: Development of Novel MRI Methods to Advance In Vivo Predictive Dissolution Studies

  Khalaf, Asseel; Hoad, Caroline; Menys, Alex; Mudie, Deanna; Wright, Jeff; Heissam, Khaled; Abrehart, Nichola; Gowland, Penny; Amidon, Gregory; Spiller, Robin; Amidon, Gordon; Marciani, Luca

• A new Particle Population Balance Model (PPB) for PBPK Modelling of Orally Dosed Drugs Accounting for Two Solid States

  Liu, Dan; Jamei, Masoud; Turner, David

• Using In Vivo Flow Rates In Usp Apparatus 4 To Develop A More In Vivo Relevant Hydrodynamic Dissolution Test.

  Krieg, Brian; Amidon, Gorgon; Amidon, Gregory

• Fasted and Fed Motility of the Undisturbed Small Bowel: Development of Novel MRI Methods to Advance In Vivo Predictive Dissolution Studies

  Khalaf, Asseel; Hoad, Caroline; Menys, Alex; Mudie, Deanna; Wright, Jeff; Heissam, Khaled; Abrehart, Nichola; Gowland, Penny; Amidon, Gregory; Spiller, Robin; Amidon, Gordon; Marciani, Luca

• Exploring Dissolution, Supersaturation and Precipitation of Posaconazolein the Gastrointestinal Simulator (GIS) In Parallel With Visualization of Precipitated Drug by Microscopy Studies

  Hens, Bart; Bermejo, Marival; Tsume, Yasuhiro; Gonzalez-Alvarez, Isabel; Ruan, Hao; Matsui, Kazuki; Amidon, Greg; Cavanagh, Katie; Kuminek, Gislaine; Rodriguez-Hornedo, Nair; Amidon, Gordon

• Dynamic Change in pH by Low Buffer Capacity of Gastrointestinal Fluids Along the Human Gastrointestinal Tract: Implications for In Vivo Dissolution and Absorption of Ionizable Compounds

  Hens, Bart; Tsume, Yasuhiro; Bermejo, Marival; Paixao, Paulo; Koenigsknecht, Mark; Baker, Jason; Hasler, William; Lionberger, Robert; Fan, Jianghong; Dickens, Joseph; Shedden, Kerby; Wen, Bo; Wysocki, Jeffrey; Loebenberg, Raimar; Lee, Allen; Frances, Ann; Amidon, Greg; Yu, Alex; Benninghoff, Gail; Salehi, Niloufar; Talattof, Arjang; Sun, Duxin; Amidon, Gordon L

• Measuring Fasted State Gastric Motility Before and After a Standard BA/BE 8 OZ Drink of Water: Validation of new MRI Imaging Protocols Against Concomitant Perfused Manometry in Healthy Participants

  Heissam, Khaled; Abrehart, Nichola; Hoad, Caroline; Wright, Jeff; Menys, Alex; Murray, Kathryn; Glover, Paul; Hebbard, Geoffrey; Gowland, P A; Baker, Jason; Hasler, W L; Spiller, R C; Corsetti, Maura; Brasseur, James; Hens, Bart; Shedden, Kerby; Dickens, J; Mudie, D M; Amidon, G E; Amidon, G L; Marciani, L

• Evaluation of U.S. FDA Approved Generic Oral Solution Products

  Hakeem, Susan; Huang, Yih-Chain; Jiang, Wenlei

• Quantitative Modeling and Simulation to Evaluate Alternative Approaches to be Used in COVID-19 Interrupted Bioequivalence Studies

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