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)

• 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

• Hydrodynamic Enhancement of Dissolution from Drug Particles: In Vivo vs. In Vitro

  Brasseur, James.; Wang, Yanxing

• Development of Generic Drug products under Suitability Petition

  Boyce, Heather

• A Review of Internal Data on Bioequivalence Studies Conducted with Soft Food Administration

  Boyce, Heather

• Impact of Excipients on Drug Permeation to Support Biowaivers for Non-Q1/Q2 Products

  Bode, Chris