ICH S9 Non-clinical evaluation for anticancer pharmaceuticals

Current effective version

PDF iconAdopted guideline

Reference numberCHMP/ICH/646107/08
Published01/05/2010
Effective from11/02/2013
KeywordsAnticancer pharmaceuticals, advanced cancer, pharmacology, pharmacokinetics, toxicology, non-clinical
Description

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:

PDF iconQuestions and answers - ICH S9 guideline on nonclinical evaluation for anticancer pharmaceuticals, Step 5


Published: 16/05/2018
Effective from: 16/11/2018


Document history

Questions and answers
(This Q&A document is intended to provide additional clarification relating to the selection and justification of starting materials)

PDF iconQuestions and answers - ICH S9 guideline on nonclinical evaluation for anticancer pharmaceuticals, Step 2b

PDF iconOverview of comments

Published: 28/06/2016

Published: 13/02/2017


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