Drug Regulators, EMEA, Publish ICH S9 Guidance, Nonclinical Evaluation for Anticancer Pharmaceuticals
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The purpose of this guidance is to provide information to assist in the design of an appropriate program of nonclinical studies for the development of anticancer pharmaceuticals. The guidance provides recommendations for nonclinical evaluations to support the development of anticancer pharmaceuticals in clinical trials for the treatment of patients with advanced disease and limited therapeutic options.
This guideline aims to facilitate and accelerate the development of anticancer pharmaceuticals and to protect patients from unnecessary adverse effects, while avoiding unnecessary use of animals, in accordance with the 3R principles (reduce/refine/replace), and other resources.
As appropriate, the principles described in other ICH guidelines should be considered in the development of anticancer pharmaceuticals. Specific situations where recommendations for nonclinical testing deviate from other guidance are described in this document.
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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
