Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals

Issue Date: May 8, 2001
Issued by: Center for Drug Evaluation and Research
Topic(s): Pharmacology/Toxicology
Status: Draft

Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals.” The purpose of this document is to provide guidance to sponsors on the design of animal carcinogenicity experiments, methods of statistical analysis of tumor data, interpretation of study results, presentation of data and results in reports, and the submission of tumor data to FDA statistical reviewers in the Center for Drug Evaluation and Research (CDER).

Download the Guidance Document