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)

• The Effects of Excipients on Intestinal Drug Transporters

  Giacomini, Kathy

• Updates to the Simcyp Simulator’s ADAM / M-ADAM Models

  Turner, David

• Modeling Gastrointestinal Lumical Drug Precipitation

  Turner, David

• In Vitro Drug Release Testing for Complex Generics: A Bioequivalence Perspective

  Wang, Yan

• Potential Impact of Gastric pH on Generic Drug Bioequivalence Evaluation

  Fan, Jianghong

• PBPK Absorption Modeling to Support Risk Assessment and Biowaiver for Generic Oral Products

  Wu, Fang

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

  Donnelly, Mark

• Regulatory Research on the Effect of Excipients on Drug Absorption

  Zhang, Lei

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

  Brasseur, James.; Wang, Yanxing

• Essential Elements of BCS III-Based Biowaiver Request

  Zhang, Yi