ICH S9 Non-clinical evaluation for anticancer pharmaceuticals

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Current effective version

Adopted guideline

Reference numberCHMP/ICH/646107/08
Effective from11/02/2013
KeywordsAnticancer pharmaceuticals, advanced cancer, pharmacology, pharmacokinetics, toxicology, non-clinical

This document aims to assist in the design of non-clinical studies for the development of anticancer pharmaceuticals. It provides recommendations for non-clinical evaluations to support the development of anticancer pharmaceuticals in clinical trials for the treatment of patients with advanced disease and limited therapeutic options. 

Read together with:

Questions and answers - ICH S9 guideline on nonclinical evaluation for anticancer pharmaceuticals, Step 2b (EMA/CHMP/ICH/453684/2016)


Overview of comments Published: 13/02/2017

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