ICH S9 Non-clinical evaluation for anticancer pharmaceuticals - Scientific guideline
Table of contents
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.
Keywords: Anticancer pharmaceuticals, advanced cancer, pharmacology, pharmacokinetics, toxicology, non-clinical
Read together with:
Published: 16/05/2018
Effective from: 16/11/2018
This Q&A document is intended to provide additional clarification relating to the selection and justification of starting materials
-
List item
ICH S9 guideline on nonclinical evaluation for anticancer pharmaceuticals - questions and answers - Step 5 (PDF/492.86 KB)
Adopted
First published: 16/05/2018
Last updated: 16/05/2018
EMA/CHMP/ICH/453684/2016 -
List item
Overview of comments received by EMA on 'Questions and answers - ICH S9 guideline on nonclinical evaluation for anticancer pharmaceuticals - Step 2b' (PDF/156.68 KB)
First published: 13/02/2017
Last updated: 13/02/2017
EMA/72007/2017