Repeated dose toxicity
This 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.
Keywords: Repeated dose toxicity, study design, choice of species, list of tissues
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Guideline on repeated dose toxicity - Revision 1 (PDF/190.89 KB)
Adopted
First published: 29/03/2010
Last updated: 05/11/2010
Legal effective date: 01/09/2010
CPMP/SWP/1042/99 Rev 1 Correction -
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Overview of comments received on guideline on repeated dose toxicity (CPMP/SWP/1042/99 Rev 1) (PDF/248.77 KB)
First published: 29/03/2010
Last updated: 05/11/2010
EMA/402716/2008 Correction -
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Draft guideline on repeated dose toxicity (PDF/71.22 KB)
Draft: consultation closed
First published: 21/02/2008
Last updated: 21/02/2008
Consultation dates: 21/02/2008 to 30/05/2008
EMEA/CHMP/SWP/488313/2007