Spring Intro 2023

03/03/2023

The Nonclinical Overview

It is important to realise that the Non-Clinical Overview is sometimes the FIRST document a reviewer reads.

FIRST IMPRESSIONS CAN COUNT!!!

33

The Nonclinical Overview Where relevant guidelines exist, these should be taken into consideration and any “deviations” should be commented upon and justified. The testing strategy should be discussed and justified. The GLP status of the studies submitted should be commented on, i.e. confirm OECD GLP requirements met.

34