Verification of a false positive in a two-year rat carcinogenicity study using dual control groups-Reference-Cited by-同舟云学术

Verification of a false positive in a two-year rat carcinogenicity study using dual control groups

Published:2018 Issue:9 Volume:43 Page:557-563
ISSN:0388-1350
Container-title:The Journal of Toxicological Sciences
language:en
Short-container-title:J. Toxicol. Sci.

Author:

Ogawa Shuji¹,Kuroda Hiroyuki²,Kinomoto Toshiko¹,Kawabata Yoshihiro¹,Kawabe Mayumi³,Suguro Mayuko³,Oishi Yuji⁴

Affiliation:

1. Central Research Laboratories, Zeria Pharmaceutical Co., Ltd.

2. R&D PLANNING, Zeria Pharmaceutical Co., Ltd.

3. DIMS Institute of Medical Science, Inc.

4. Department Molecular Pathology, Osaka City University

Publisher

Japanese Society of Toxicology

Subject

Toxicology

Link

https://www.jstage.jst.go.jp/article/jts/43/9/43_557/_pdf

Reference18 articles.

1. Ando, R., Nakamura, A., Nagatani, M., Yamakawa, S., Ohira, T., Takagi, M., Matsushima, K., Aoki, A., Fujita, Y. and Tamura, K. (2008): 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.

2. Baldrick, P. (2005): Carcinogenicity evaluation: comparison of tumor data from dual control groups in the Sprague-Dawley rat. Toxicol. Pathol., 33, 283-291.

3. Baldrick, P. and Reeve, L. (2007): Carcinogenicity evaluation: comparison of tumor data from dual control groups in the CD-1 mouse. Toxicol. Pathol., 35, 562-569.

4. CDER (2001): Guidance for industry: statistical aspects of the design, analysis, and interpretation of chronic rodent carcinogenicity studies of pharmaceuticals. Issued as draft document in May 2001.

5. DIMS (2015): Standards for Care and Use of Laboratory Animals at DIMS Institute of Medical Science, Inc.