GDUFA Research Outcomes

MR Oral Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to modified release generic drug products.

• All(50)
• Posters(23)
• Presentations(18)
• Papers(9)

• FEV1 Based Bioequivalence Study for Inhaled Corticosteroids

  Zhao, Liang

• Use of Modeling and Simulation to Support New BE Approaches

  Zhao, Liang

• 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

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

  Wang, Yan

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

  Tan, Ming-Liang

• Establishing Bioequivalence for Generic Oral Modified-Release Products: Regulatory Considerations and Utility of In Vivo Predictive Dissolution

  Lee,Sue-Chih

• Modeling for Success: A Case Example for Oseltamivir Phosphate

  Mousa, Youssef

• Generic Versions of Narrow Therapeutic Index Drugs National Survey of Pharmacists’ Substitution Beliefs and Practices

  Jiang, Wenlei

• In Vivo Relevance of Dissolution

  Jiang, Wenlei