More on first-in-man studies.

摘要

In October's'Editors' view' we visited the art and science of estimating an appropriate dose for first-in-human studies [1].ln this issue of the Journal we publish a safety grading scale to support dose escalation during single ascending dose (SAD) and multiple ascending dose (MAD) early phase studies in healthy young adult men [2]. It describes how such grading can be used to help decide whether to stop the study or to continue dose escalation.