The Society of Toxicologic Pathology's Recommendations on Statistical Analysis of Rodent Carcinogenicity Studies

Bieler GS , Williams RL (1993). Ratio estimates, the Delta method, and quantal response tests for increased carcinogenicity. Biometrics 49: 793— 801.

Gad SC , Rousseaux CG (2002). Use and misuse of statistics inthe design and interpretation of studies. In: Handbook of Toxicologic Pathology , Haschek WM , Rousseaux CG , Wallig MA (eds). Academic Press, San Diego, 2nd Edition, Volume 1, Chapter 15, pp 327—418.

Lee PN , Fry JS , Fairweather WR , Haseman JK , Kodell RL , Chen JJ , Roth AJ , Soper K. , Morton D. (2002). Current issues statistical methods for carcinogenicity studies. Toxicol Pathol (in press).

Offi ce of the Federal Register (2001). Guidance for industry—statistical aspects of the design, analysis, and interpretation of chronic rodent carcinogenicity studies of pharmaceuticals (draft guidance). Federal Register 66(89), May 8, 2001, 23266—23267.

Peto R. , Pike M. , Day NE , Gray RG , Lee PN , Parish S. , Peto J. , Richards S. , Wahrendorf J. (1980). Guidelines for simple, sensitive signifi cance tests for carcinogenic effects in long-term animal experiments. In: IARCMonographs on the Evaluation of Carcinogeni c Risk of Chemicals to Humans, Supplement of Long-term and Short-term Screening Assays for Carcinogens: A Critical Appraisal. International Agency for Research on Cancer, Lyon, France, Supplement 2, pp 311—426.

STP Peto Working Group ( 2001). Draft recommendations on classifi- cation of rodent neoplasms for Peto analysis. Toxicol Pathol 29: 265— 268.