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(237)
• Posters(60)
• Presentations(64)
• Papers(113)

• 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

• Phase Behavior and Tranformation Kinetics of A Poorly Water Soluble Weakly Basic Drug upon Transit from Low to High PH Conditions

  Duong, Tu; Turner, David; Taylor, Lynne

• Metabolic Kinetics of Bupropion in Human Liver and Intestinal Subcellular Fractions

  Sun, Duxin

• Formulation Design Considerations And Pharmacokinetics Assessments Of Bupropion Drug Products

  Connarn, Jamie; Li, Yan; Zhou, Simon; Zhang, Xinyuan; Babiskin, Andrew; Fan, Jianghong; Amini, Thushi; Sun, Duxin

• PBPK Modeling for Predicting the In Vivo Performance and Product Quality of Tacrolimus and Itraconazole Amorphous Solid Dispersions in Humans

  Chow, Edwin; Sun, Dajun; Fang, Lanyan; Wen, Hong; Zhao, Liang; Lapteva, Larissa; Jiang, Wenlei; Lionberger, Robert

• Assessment on the Formulation Similarity of Approved Generic Drug Products and their Respective Reference Products Which are Considered as Potential BCS Class 3 Drugs

  Chan, Theresa; Ren, Ping; Yang, Wen Cheng; Wang, Yan; Luke, Markham; Kim, Myong Jin; Zhang, Yi