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

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Current effective version

Revision 2 - Adopted guideline

Reference numberCPMP/ICH/286/95
Published11/02/2013
Effective from01/12/2009
KeywordsNon-clinical safety, clinical trials, pharmacology, toxicokinetics, toxicity, dose selection
DescriptionThis 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.


Document history

Revision 2

Current version

Adopted guideline


Draft guideline

In operation: 01/12/2009–present


Published: 01/07/2008


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