Transition of Historical Control Data for High Incidence Tumors in F344 Rats

Author:

KUROIWA Yuichi1,ANDO Ryo2,KASAHARA Kenichiro2,NAGATANI Mariko2,YAMAKAWA Seiki2,OKAZAKI Shuzo1

Affiliation:

1. Toxicology Division, Gotemba Laboratory, BoZo Research Center Inc., 1284 Kamado, Gotemba, Shizuoka 412-0039, Japan

2. Pathology Division, Gotemba Laboratory, BoZo Research Center Inc., 1284 Kamado, Gotemba, Shizuoka 412-0039, Japan

Publisher

Japanese Society of Toxicologic Pathology

Subject

Toxicology,Pathology and Forensic Medicine

Reference13 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 carcinogenicity studies of pharmaceuticals. Draft guidance. U.S. Department of Health and Human Services, FDA and CDER. 2001.

3. 3. Ando R, Nakamura A, Nagatani M, Yamakawa S, Ohira T, Takagi M, Matsushima K, Aoki A, Fujita Y, and Tamura K. Comparison of past and recent historical control data in relation to spontaneous tumors during carcinogenicity testing in Fischer 344 rats. J Toxicol Pathol. 21: 53-60. 2008.

4. 4. Maita K, Hirano M, Harada T, Mitsumori K, Yoshida A, Takahashi K, Nakashima N, Kitazawa T, Enomoto A, Inui K, and Shirasu Y. Spontaneous tumors in F344/DuCrj rats from 12 control groups of chronic and oncogenicity studies. J Toxicol Sci. 12: 111-126. 1987.

5. 5. Iwata H, Hirouchi Y, Koike Y, Yamakawa S, Kobayashi K, Yamamoto T, Kobayashi K, Inoue H, and Enomoto M. Historical control data of non-neoplastic and neoplastic lesions in F344/DuCrj rats. J Toxicol Pathol. 4: 1-24. 1991.

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