Fiori Janice M, Meyerhoff Roger D
Toxicology and Drug Disposition, Lilly Research Laboratories, Division of Eli Lilly and Company, Greenfield, IN 46140, USA.
Regul Toxicol Pharmacol. 2002 Apr;35(2 Pt 1):209-16. doi: 10.1006/rtph.2002.1534.
Risk assessment processes for carcinogens are highly developed but risk assessment processes for mutagens are not well established. In the pharmaceutical industry, risk associated with exposure to carcinogens is tightly controlled. It is desirable to control risk associated with exposure to mutagens also, in spite of the greater uncertainty associated with the risk. In this paper, a published cancer potency database is used to frame the risk and to support risk management decisions. A de minimis exposure for mutagens is proposed and a decision matrix is presented to align available data with risk assessment approaches for carcinogens and mutagens.
致癌物的风险评估流程已高度完善，但诱变剂的风险评估流程尚未完全确立。在制药行业，与接触致癌物相关的风险受到严格控制。尽管与诱变剂相关的风险存在更大的不确定性，但同样需要控制与接触诱变剂相关的风险。在本文中，一个已发表的癌症效力数据库被用于构建风险并支持风险管理决策。本文提出了诱变剂的最低暴露标准，并给出了一个决策矩阵，以使现有数据与致癌物和诱变剂的风险评估方法保持一致。
