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)

• Advances on Using PBPK Modeling to Support BE Assessment for Oral Products

  Wu, Fang

• A Critical Overview of the Biological Effects of Excipients

  Wu, Fang; Tsakalozou, Eleftheria

• Using PBPK Model to Support Risk Assessment for Oral Products

  Wu, Fang

• Challenges and Opportunities when Using Oral PBPK to Support Risk Assessment and Biowaiver in Regulatory Submissions

  Wu, Fang

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

  Wu, Fang

• Regulatory and Scientific Considerations on Characterizations of Complex Polymeric Excipients

  Wang, Yan

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

  Wang, Yan

• Bioequivalence Approaches for Long-Acting Drug Products: Regulatory and Scientific Considerations

  Wang, Yan

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

  Turner, David

• Exploiting Dual Solid State PBPK Tools to Assess the Bio(in)equivalence of Tacrolimus Amorphous Formulations with Various Degrees of Crystallization Arising During Storage

  Turner, David