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
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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
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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 -
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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
- ICH: safety
- Non-clinical development
ICH S9 guideline on nonclinical evaluation for anticancer 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
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)