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