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Guidance for Industry: S9 Nonclinical Evaluation for Anticancer Pharmaceuticals.

PB2010107638

Publication Date	2010
Page Count	12
Abstract	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 guidance 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 guidances 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.
Keywords	Nonclinical evaluation Drugs Malignant neoplasms Cancer Guidance US FDA Dosage Clinical trials Anticancer Pharmaceuticals
Source Agency	Department of Health and Human Services, Washington, DC
Corporate Authors	Food and Drug Administration, Rockville, MD. Center for Drug Evaluation and Research.; Department of Health and Human Services, Washington, DC.
Supplemental Notes	Sponsored by Department of Health and Human Services, Washington, DC.
Document Type	Technical Report
NTIS Issue Number	201015

Guidance for Industry: S9 Nonclinical Evaluation for Anticancer Pharmaceuticals.

Guidance for Industry: S9 Nonclinical Evaluation for Anticancer Pharmaceuticals.
PB2010107638

Publication Date	2010
Page Count	12
Abstract	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 guidance 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 guidances 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.
Keywords	Nonclinical evaluation Drugs Malignant neoplasms Cancer Guidance US FDA Dosage Clinical trials Anticancer Pharmaceuticals
Source Agency	Department of Health and Human Services, Washington, DC
Corporate Authors	Food and Drug Administration, Rockville, MD. Center for Drug Evaluation and Research.; Department of Health and Human Services, Washington, DC.
Supplemental Notes	Sponsored by Department of Health and Human Services, Washington, DC.
Document Type	Technical Report
NTIS Issue Number	201015