Repeated dose toxicity - Scientific guideline

This guideline 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

Current effective version

Guideline on repeated dose toxicity - Revision 1

Adopted Reference Number: CPMP/SWP/1042/99 Rev 1 Correction Legal effective date: 01/09/2010

Document history - Revision 1 (current version)

Guideline on repeated dose toxicity - Revision 1

Adopted Reference Number: CPMP/SWP/1042/99 Rev 1 Correction Legal effective date: 01/09/2010

Overview of comments received on guideline on repeated dose toxicity (CPMP/SWP/1042/99 Rev 1)

Reference Number: EMA/402716/2008 Correction

Draft guideline on repeated dose toxicity

Draft: consultation closed Consultation dates: 21/02/2008 to 30/05/2008 Reference Number: EMEA/CHMP/SWP/488313/2007

Document history - First version

Note for guidance on repeated dose toxicity

Adopted Reference Number: CPMP/SWP/1042/99 corr. Legal effective date: 01/10/2008