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
ICH M3 (R2) - questions and answers
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Keywords: Non-clinical safety, clinical trials, pharmacology, toxicokinetics, toxicity, dose selection
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ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals - Step 5 (PDF/262.63 KB)
Adopted
First published: 11/02/2013
Last updated: 11/02/2013
Legal effective date: 01/12/2009
CPMP/ICH/286/95 -
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ICH: M 3 (R2): Non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals - Step 3 (PDF/213.91 KB)
Draft: consultation closed
First published: 01/07/2008
Last updated: 01/07/2008
Consultation dates: 01/07/2008 to 01/10/2008
CPMP/ICH/286/95-draft