Non-clinical investigation of the dependence potential of medicinal products

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Current effective version

Adopted guideline

Reference numberCHMP/SWP/94227/04
Published01/03/2006
Effective from01/09/2006
KeywordsDependence potential, non-clinical, behavioural studies, opioids, central nervous system (CNS) stimulants, sedatives, anxiolytics
DescriptionThis 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.


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