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)

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

  Zou, Ling

• Biopharmaceutic In Vitro In Vivo Extrapolation (IVIV_E) Informed Physiologically-Based Pharmacokinetic Model of Ritonavir Norvir Tablet Absorption in Humans Under Fasted and Fed State Conditions

  Arora, Sumit

• Screening Oral Excipients against P-glycoprotein

  Bajaj, Ruchika

• 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

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

  Tampal, Nilufer

• 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