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GUIDANCE DOCUMENT

S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals September 2008

Download the Final Guidance Document
Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance provides recommendations for dose selection for carcinogenicity studies of human pharmaceuticals. The guidance is intended to aid sponsors in selecting appropriate doses for rodent carcinogenicity studies.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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