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)

• Physiologically Based Pharmacokinetic Modeling for BCS IV Drugs and Case Examples

  Wu, Fang

• Totality of Evidence Including PBPK Modeling to Support BE Assessment and Approval of Mesalamine Delayed Release Tablets (Part II)

  Wu, Fang

• Physiologically Based Pharmacokinetic Absorption Modeling to Support BCS-Based Waiver of In Vivo Bioequivalence Studies

  Wu, Fang

• Regulatory Perspective of Model Master Files Utilities for Oral Drug Products

  Wu, Fang

• 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