ICH S9 Non-clinical evaluation for anticancer pharmaceuticals - Scientific guideline

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:

ICH S9 guideline on nonclinical evaluation for anticancer pharmaceuticals - questions and answers - Step 5

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

Current effective version

Questions and answers

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

Related content

• ICH: safety
• Non-clinical development
• ICH S9 guideline on nonclinical evaluation for anticancer 4 pharmaceuticals - questions and answers - Step 2b
• ICH M3 (R2) Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals
• ICH Q3A (R2) Impurities in new drug substances
• ICH Q3B (R2) Impurities in new drug products
• ICH S1A Need for carcinogenicity studies of pharmaceuticals
• ICH S2 (R1) Genotoxicity testing and data interpretation for pharmaceuticals intended for human use
• ICH S5 (R2) Detection of toxicity to reproduction for medicinal products and toxicity to male fertility
• ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals
• ICH S7A Safety pharmacology studies for human pharmaceuticals
• ICH S7B Non-clinical evaluation of the potential for delayed ventricular repolarisation (QT interval prolongation) by human pharmaceuticals

External links

• ICH S9 Step 4 Presentation (see S9 Step 4 Presentation under S9 Nonclinical evaluation for Anticancer Pharmaceuticals: S9: WG Presentations / Trainings)

• ICH S9 Q&As Step 4 Presentation (see S9 Q&As Step 4 Presentation under S9 Nonclinical evaluation for Anticancer Pharmaceuticals: S9 Q&As: WG Presentations / Trainings)