Repeated dose toxicity

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Current effective version

Revision 1 - Adopted guideline

Reference numberCPMP/SWP/1042/99 Rev. 1 Corr.
Effective from01/09/2010
KeywordsRepeated dose toxicity, study design, choice of species, list of tissues
DescriptionThis document applies to the conduct of repeated dose toxicity studies of active substances intended for human use. It provides guidance on the choice of animal species, the size of groups, animal husbandry and parameters to be monitored during the in-life phase of a study.

Document history

Revision 1 

Current version

Adopted guideline


Overview of comments


Draft guideline

In operation: 01/09/2010–present


Published: 29/03/2010


Published: 21/02/2008

First versionAdopted guidelineIn operation: 01/10/2008–31/08/2010

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