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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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

ICH guideline S9 on non-clinical evaluation for anticancer pharmaceuticals - Step 5

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Questions and answers

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

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

English (EN) (492.86 KB - PDF)View

Overview of comments received by EMA on 'Questions and answers - ICH S9 guideline on nonclinical evaluation for anticancer pharmaceuticals - Step 2b'

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