Extending the threshold of regulation concept:: De minimis limits for carcinogens and mutagens

被引：20

作者：

Fiori, JM ^{[1
]}

Meyerhoff, RD ^{[1
]}

机构：

[1] Eli Lilly & Co, Lilly Res Labs, Toxicol & Drug Disposit, Greenfield, IN 46140 USA

来源：

REGULATORY TOXICOLOGY AND PHARMACOLOGY | 2002年 / 35卷 / 02期

关键词：

safety evaluation; mutagens; de minimis; carcinogens; risk assessment;

D O I：

10.1006/rtph.2002.1534

中图分类号：

DF [法律]; D9 [法律]; R [医药、卫生];

学科分类号：

0301 ; 10 ;

摘要：

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. (C) 2002 Elsevier Science (USA).

引用

页码：209 / 216

页数：8

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