S9 Nonclinical Evaluation for Anticancer Pharmaceuticals

Issue Date: March 8, 2010
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Safety
Status: Final

S9 Nonclinical Evaluation for Anticancer Pharmaceuticals

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.

Download the Guidance Document

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