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International Comparison of Process and Procedures to Overcome Clinical Trial Applications Placed on Clinical Hold

Time

Tue, Jun 17 7:15AM
T 35

Title

International Comparison of Process and Procedures to Overcome Clinical Trial Applications Placed on Clinical Hold

Abstract Summary

Clinical Trial Applications for first-in-human studies for two, orally administered molecules were submitted (Compound A: investigation new drug application(IND), Compound B: clinical trial authorisation(CTA)). Both were denied and the processes from denial to the “may-proceed” status are compared.

Poster Presenter

Kenichi Otani
PhD,
Director,
Sunovion Pharmaceuticals Inc.
United States