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)

• Use of Modeling and Simulation to Support New BE Approaches

  Zhao, Liang

• Introduction & Overview: Current Regulatory Horizon of Narrow Therapeutic Index Drugs & ICH Guideline Development for Bioequivalence Assessment

  Zhang, Lei

• Opening Remarks – Global Bioequivalence Harmonization: Enhancing Access to Affordable Medicines

  Zhang, Lei

• Regulatory Science to Support Global Harmonization for Establishing BE for Generic Oral Products

  Zhang, Lei

• ICH M13 Guideline Series

  Zhang, Lei

• Essential Elements of BCS III-Based Biowaiver Request

  Zhang, Yi

• Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA

  Tampal, Nilufer

• Regulatory Research on the Effect of Excipients on Drug Absorption

  Zhang, Lei

• Biopharmaceutics Classification System Class 3 Waiver

  Zhang, Yi

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

  Zhang, Lei