Comparison of Past and Recent Historical Control Data in Relation to Spontaneous Tumors During Carcinogenicity Testing in Fischer 344 Rats

Author:

Ando Ryo1,Nakamura Atsushi1,Nagatani Mariko2,Yamakawa Seiki2,Ohira Toko2,Takagi Mizuho1,Matsushima Keita1,Aoki Ami1,Fujita Yumiko1,Tamura Kazutoshi1

Affiliation:

1. Pathology Division, Gotemba Laboratories, Bozo Research Center Inc.

2. Hamamatsu Branch, Pathology Division, Bozo Research Center Inc.

Publisher

Japanese Society of Toxicologic Pathology

Subject

Toxicology,Pathology and Forensic Medicine

Reference31 articles.

1. 1. Peto R, Pike MC, Day NE, Lee PN, Parish S, Peto J, Richard S, and Wahrendorf J. Guidelines for simple, sensitive tests for carcinogenic effects in long-term animal experiments. IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Suppl. 2: 365-367. 1980.

2. 2. Guidance for industry: Statistical aspect of the design, analysis, and interpretation of chronic rodent carcinogenidity studies of pharmaceuticals. Draft guidance. U.S. Department of Health and Human Services, FDA, and CDER. 2001.

3. 3. Tennekes H, Gembardt C, Dammann M, and van Ravenzwaay B. The stability of historical control data for common neoplasms in laboratory rats: adrenal gland (medulla), mammary gland, liver, endocrine pancreas and pituitary gland. Regul Toxicol Pharmacol. 40: 18-27. 2004.

4. 4. Tennekes H, Kaufmann W, Dammann M, and van Ravenzwaay B. The stability of historical control data for common neoplasms in laboratory rats and the implications for carcinogenic risk assessment. Regul Toxicol Pharmacol. 40: 293-304. 2004.

5. The Biosure Study: Influence of Composition of Diet and Food Consumption on Longevity, Degenerative Diseases and Neoplasia in Wistar Rats Studied for up to 30 Months Post Weaning

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