The following table provides a list of the most common pre-approval regulatory documents for drugs with their associated guidelines and regulations. The clinical study report (p86), clinical study protocol (p93), investigator's brochure (p96), and common technical document (and components; p101) are dealt with in detail elsewhere in this issue.
Editor-in-Chief:
Co-Editor:
Managing Editor
Associate Editors:
Section Editors:
Ad-hoc Editors:
Editor Emeritus: