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Journal ArticleDOI

How sick a patient? Report of a workshop on cancer risk assessment.

Gio Batta Gori, +1 more
- 01 Dec 1991 - 
- Vol. 14, Iss: 3, pp 215-222
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TLDR
Cancer risk assessment is governed by arbitrary policy assumptions and procedures improperly disguised as scientific and is designed to overestimate risk, which may adversely affect standards of living and the very health and longevity that regulation is presumed to safeguard.
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This article is published in Regulatory Toxicology and Pharmacology.The article was published on 1991-12-01. It has received 11 citations till now.

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Involvement of 8-Hydroxyguanine Formation in the Initiation of Rat Liver Carcinogenesis by Low Dose Levels of N-Nitrosodiethylamine

TL;DR: It is indicated that 8-OHG formation in the liver DNA may be involved in DEN initiation of hepatocarcinogenesis even at low dose levels, and that single i.p. doses of 0.001-0.1 and 1-100 mg/kg body weight might exert different effects.
Journal ArticleDOI

Rodent carcinogens: setting priorities

TL;DR: Results indicate that, when viewed against the large background of naturally occurring carcinogens in typical portions of common foods, the residues of synthetic pesticides or environmental pollutants rank low, and cast doubt on the relative importance for human cancer of low-dose exposures to synthetic chemicals.
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Rodent carcinogenicity tests need be no longer than 18 months: an analysis based on 210 chemicals in the IARC monographs.

TL;DR: Termination of rodent carcinogenicity studies at 18 months or earlier would greatly reduce the complications that arise in interpreting the findings in aged animals which often have defective hepatic or renal function and would also markedly reduce the time required for histopathological examination of dozens of tissues taken from the approximately 500 animals routinely employed in these studies.
Journal ArticleDOI

Are lifespan rodent carcinogenicity studies defensible for pharmaceutical agents

TL;DR: The use of rodents are highly misleading as predictors of human cancer risk and the value of the bioassay is itself questionable.
Journal ArticleDOI

Evaluation of the carcinogenic potential of pharmaceuticals. Opportunities arising from the International Conference on Harmonisation.

TL;DR: Recognition of the 4 properties (genotoxicity, immunosuppression, steroid hormonal activity and long term tissue damage), at least one of which is associated with each of the pharmaceuticals known to be carcinogenic to humans, should focus more attention on a search for these properties in patients.
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