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- W2497831231 abstract "Abstract Thresholds of exposures to genotoxic agents have been discussed for a long time, and experimental demonstrations of this could result in the establishment of acceptable daily intakes for managing risks associated with genotoxic carcinogens. Virtually safe doses (VSDs) and thresholds of toxicological concern (TTC) have also been used to ensure sufficiently low concentrations of carcinogenic chemicals. Accordingly, the ICH-M7 guideline Assessment and Control of DNA-Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, finalized in Jun. 2014, highlights various assessments of genotoxic and mutagenic hazards to reduce the potential lifetime cancer risk from genotoxic impurities during clinical development and after approval of pharmaceutical agents. In this chapter, the concepts of VSD and TTC for managing risk associated with genotoxic carcinogens contained in pharmaceutical agents are reviewed." @default.
- W2497831231 created "2016-08-23" @default.
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- W2497831231 date "2016-01-01" @default.
- W2497831231 modified "2023-09-24" @default.
- W2497831231 title "Thresholds of Toxicological Concern for Genotoxic Impurities in Pharmaceuticals" @default.
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- W2497831231 doi "https://doi.org/10.1016/b978-0-12-801663-3.00007-8" @default.
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