ICH S9 Non-clinical evaluation for anticancer pharmaceuticals

  • Email
  • Help
Current effective version

Adopted 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:

Questions 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)

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

 

Overview of comments

Published: 28/06/2016
 
 

Published: 13/02/2017


Related content


How helpful is this page?

Average rating:

 Based on 46 ratings

Add your rating:

See all ratings
9 ratings
9 ratings
9 ratings
9 ratings
10 ratings
    

Tell us more