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)

• 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

• 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

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

  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

• Excipient Similarity in Generic Formulations Containing Biopharmaceutics Classification System 3 Drugs

  Chan, Theresa; Ren, Ping; Yang, Wencheng; Wang, Yan; Luke, Markham; Jiang, Xiaohui; Zhang, Yi

• Using the In-vitro Dissolution Absorption System (IDAS) to Evaluate the Effects of Excipients on the Permeation of Putative Biopharmaceutics Classification System Class III Drugs

  Bode, Chris; Bhoopathy, Sid; Miezeiewski, Blair; Wu, Fang; Ren, Ping; Wang, Zhong; Zhao, Liang

• In Vitro Comparative Dissolution and Permeation Testing Using the In-vitro Dissolution Absorption System (IDAS) for Expanding Biowaivers to Non Q1/Q2 BCS Class III Products

  Bode, Chris; Bhoopathy, Sid; Miezeiewski, Blair; Wu, Fang; Ren, Ping; Wang, Zhong; Zhao, Liang

• The Interplay Between Pharmaceutical Dissolution and Absorption in the Human Gut Studied with Computer Simulation

  Behafarid, F; Vijayakumar, G; Brasseur, J G

• Assessing the Bioequivalence of Tacrolimus Amorphous Formulations with Varying Degrees of Crystallinity using Mechanistic Dissolution Models in a Population Physiologically-based Pharmacokinetic (PBPK) Modelling Framework

  Arora, Sumit; Patel, Nikunjkumar; Jamei, Masoud; Turner, David