GDUFA Research Outcomes

Human Subject Safety

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to the safety of human subjects in bioequivalence studies for generic products.

• All(14)
• Posters(1)
• Presentations(12)
• Papers(1)

• Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop

  Zhang, Xinyuan; Duan, John; Kesisoglou, Filippos; Novakovic, Jasmina; Amidon, Gordon; Jamei, Masoud; Lukacova, Viera; Eissing, Thomas; Tsakalozou, Eleftheria; Zhao, Liang; Lionberger, Robert

• 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

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

  Zhang, Lei

• Regulatory and Scientific Considerations on Characterizations of Complex Polymeric Excipients

  Wang, Yan

• 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

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

  Jiang, Wenlei

• In Vivo Relevance of Dissolution

  Jiang, Wenlei