Issue Date: September 17, 2008
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Safety
Status: Final
S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals
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.
Download the Guidance Document
