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)

• Influence of Non-homogeneous Particle Distributions on Drug Release in a Couette In vitro Dissolution Device

  Jayaraman, Balaji; Brasseur, James; Wang, Yanxing

• Equivalence Criteria for In Vitro BE Tests for Locally Acting Drug Products: The Earth Mover’s Distance Approach

  Hu, Meng

• Alternative Model-Based Data Analysis Approach to Demonstrate Bioequivalence

  Gong, Yuqing

• Alternative BE Approaches for Data Analysis Due To COVID-19 Related Study Interruptions

  Gong, Yuqing

• The Effects of Excipients on Intestinal Drug Transporters

  Giacomini, Kathy

• The Effects of Excipients on Intestinal Drug Transporters

  Giacomini, Kathy

• Narrow Therapeutic Index Drug Classification: US FDA Current Process

  Fang, Lanyan

• Potential Impact of Gastric pH on Generic Drug Bioequivalence Evaluation

  Fan, Jianghong

• Regulatory Challenges with Pharmacokinetic (PK) Bioequivalence (BE) Studies for Drugs Containing Endogenous Compounds

  Donnelly, Mark

• A Literature Review on the Performance of Tiny Tract for In Vitro Modeling (tiny-TIM) to Predict Food-Drug and pH-Dependent Drug-Drug Interaction Risks

  Chang, Yuhua; Zhao, Gang; Nguyen, Duyen; Zhang, Qi; Lim, Hye-Lim