Transition of Historical Control Data for High Incidence Tumors in F344 Rats
Author:
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
Link
https://www.jstage.jst.go.jp/article/tox/26/2/26_2012-0048/_pdf
Reference13 articles.
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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 Draft guidance.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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