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)

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

  Bode, Chris

• Intestinal Influx Transporters: A Missing Piece in the Puzzle?

  Zhang, Lei

• 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

• Regulatory and Scientific Considerations on Characterizations of Complex Polymeric Excipients

  Wang, Yan

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

  Wang, Yan

• 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

• PBPK Modeling of Supersaturating Drug Products

  Turner, David

• Reverse Translational Assessment of CYP450- and OATP-Mediated Clearance in Chronic Kidney Disease: from Clinical Data to PBPK Modeling

  Tan, Ming-Liang

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

  Gong, Yuqing