ICH M3 (R2) Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals - Scientific guideline

This document aims to recommend international standards for the non-clinical safety studies recommended to support human clinical trials as well as marketing authorization for pharmaceuticals. Read together with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M3 (R2) questions and answers - Step 5.

Keywords: Non-clinical safety, clinical trials, pharmacology, toxicokinetics, toxicity, dose selection

Current effective version

ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals - Step 5

Adopted Reference Number: CPMP/ICH/286/95 Legal effective date: 01/12/2009

Document history - Revision 2 (current version)

ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals - Step 5

Adopted Reference Number: CPMP/ICH/286/95 Legal effective date: 01/12/2009

ICH: M 3 (R2): Non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals - Step 3

Draft: consultation closed Consultation dates: 01/07/2008 to 01/10/2008 Reference Number: CPMP/ICH/286/95-draft