Non-clinical investigation of the dependence potential of medicinal products - Scientific guideline

This document describes the need for testing of dependence potential in animals during the development of pharmaceuticals. It indicates what type of information is expected to support the assessment of human safety with respect to dependence potential of a medicinal product.

Keywords: Dependence potential, non-clinical, behavioural studies, opioids, central nervous system (CNS) stimulants, sedatives, anxiolytics

Current effective version

Guideline on the non-clinical investigation of the dependence potential of medicinal products

Adopted Reference Number: EMEA/CHMP/SWP/94227/2004 Legal effective date: 01/03/2006