Potentially mutagenic impurities: Analysis of structural classes and carcinogenic potencies of chemical intermediates in pharmaceutical syntheses supports alternative methods to the default TTC for calculating safe levels of impurities-Reference-Cited by-同舟云学术

Potentially mutagenic impurities: Analysis of structural classes and carcinogenic potencies of chemical intermediates in pharmaceutical syntheses supports alternative methods to the default TTC for calculating safe levels of impurities

Published:2013-08 Issue:3 Volume:66 Page:326-335
ISSN:0273-2300
Container-title:Regulatory Toxicology and Pharmacology
language:en
Short-container-title:Regulatory Toxicology and Pharmacology

Author:

Galloway Sheila M.,Vijayaraj Reddy M.,McGettigan Katherine,Gealy Robert,Bercu Joel

Publisher

Elsevier BV

Subject

Toxicology,General Medicine

Reference52 articles.

1. Chemical structure, Salmonella mutagenicity and extent of carcinogenicity as indicators of genotoxic carcinogenesis among 222 chemicals tested in rodents by the U.S. NCI/NTP;Ashby;Mutat. Res.,1988

2. Definitive relationships among chemical structure, carcinogenicity and mutagenicity for 301 chemicals tested by the U.S. NTP;Ashby;Mutat. Res.,1991

3. Threshold of toxicological concern for chemical substances present in the diet. Report of a workshop, 5–6 October 1999, Paris, France;Barlow;Food Chem. Toxicol.,2001

4. Quantitative assessment of cumulative carcinogenic risk for multiple genotoxic impurities in a new drug substance;Bercu;Regul. Toxicol. Pharmacol.,2008

5. In silico approaches to predicting cancer potency for risk assessment of genotoxic impurities in drug substances;Bercu;Regul. Toxicol. Pharmacol.,2010

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