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)

• Interactions of Azo Dyes Commonly Used in Oral Drug Products with the Organic Anion Transporting Polypeptide 2B1 (OATP2B1) and Human Gut Bacteria

  Zou, Ling

• Quantitative Methods and Modeling to Evaluate Alternative Approaches for COVID-19 Interrupted Bioequivalence Studies

  Zhao, Liang

• FEV1 Based Bioequivalence Study for Inhaled Corticosteroids

  Zhao, Liang

• 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