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Statistical considerations in the interpretation of negative carcinogenicity data.
The regulation of toxic substances present in the environment requires that carcinogens be distinguished from noncarcinogens on the strength of the available toxicological and epidemiological evidence for carcinogenicity. In this article, we consider the difficulties associated with establishing strong evidence against carcinogenicity. In particular, the ability of both animal and human studies to detect small increases in tumor occurrence rates is evaluated in statistical terms. Consideration is also given to resolving apparent conflicts between the toxicological and the epidemiological sources of data.
Authors
- Krewski, D, Krewski D, Environmental Health Directorate, Health & Welfare Canada, Ottawa, Ontario.
- Goddard, M J, Goddard MJ,
- Murdoch, D, Murdoch D,
YEAR OF PUBLICATION: 1989
SOURCE: Regul Toxicol Pharmacol. 1989 Feb;9(1):5-22. doi: 10.1016/0273-2300(89)90041-x.
JOURNAL TITLE ABBREVIATION: Regul Toxicol Pharmacol
JOURNAL TITLE: Regulatory toxicology and pharmacology : RTP
ISSN: 0273-2300 (Print) 0273-2300 (Linking)
VOLUME: 9
ISSUE: 1
PAGES: 5-22
PLACE OF PUBLICATION: Netherlands
ABSTRACT:
The regulation of toxic substances present in the environment requires that carcinogens be distinguished from noncarcinogens on the strength of the available toxicological and epidemiological evidence for carcinogenicity. In this article, we consider the difficulties associated with establishing strong evidence against carcinogenicity. In particular, the ability of both animal and human studies to detect small increases in tumor occurrence rates is evaluated in statistical terms. Consideration is also given to resolving apparent conflicts between the toxicological and the epidemiological sources of data.
The regulation of toxic substances present in the environment requires that carcinogens be distinguished from noncarcinogens on the strength of the available toxicological and epidemiological evidence for carcinogenicity. In this article, we consider the difficulties associated with establishing strong evidence against carcinogenicity. In particular, the ability of both animal and human studies to detect small increases in tumor occurrence rates is evaluated in statistical terms. Consideration is also given to resolving apparent conflicts between the toxicological and the epidemiological sources of data.
LANGUAGE: eng
DATE OF PUBLICATION: 1989 Feb
DATE COMPLETED: 19890906
DATE REVISED: 20191029
MESH DATE: 1989/02/01 00:01
EDAT: 1989/02/01 00:00
STATUS: MEDLINE
PUBLICATION STATUS: ppublish
OWNER: NLM
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Chief Risk Scientist
Dr. Daniel Krewski is Chief Risk Scientist and co-founder of Risk Sciences International (RSI), a firm established in 2006 to bring evidence-based, multidisciplinary expertise to the challenge of understanding, managing, and communicating risk. As RSI’s inaugural CEO and long-time scientific...