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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Effective from: 16/11/2018
Current effective version
ICH guideline S9 on non-clinical evaluation for anticancer pharmaceuticals - Step 5
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
Overview of comments received by EMA on 'Questions and answers - ICH S9 guideline on nonclinical evaluation for anticancer pharmaceuticals - Step 2b'