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)

• 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

• Fasted State Motility-Dependent Transit And Dissolution Of Ibuprofen.

  Amidon, G L

• Assessing the Impact of Excipient and Food Intake on Bioequivalence Using PBPK and Virtual Bioequivalence Trial: A Case Example with Acyclovir Immediate Release Tablets

  Al Shoyaib, Abdullah; Fang, Lanyan; Zhao, Liang; Wu, Fang