Repeated dose toxicity - Scientific guideline

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

Current effective version

Guideline on repeated dose toxicity - Revision 1

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

Document history - Revision 1 (current version)

Guideline on repeated dose toxicity - Revision 1

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

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

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

Document history - First version

Note for guidance on repeated dose toxicity

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