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Regulation of impurities in drug substances and products

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Risk assessment for effects that<br />

are thought to have thresholds<br />

“…..there is some dose below which the<br />

probability <strong>of</strong> an <strong>in</strong>dividual respond<strong>in</strong>g is<br />

zero”. Casarett <strong>and</strong> Doull.<br />

Thresholds have traditionally been<br />

assumed for all toxicities with the<br />

exception <strong>of</strong> mutagenicity <strong>and</strong><br />

carc<strong>in</strong>ogenicity<br />

carc<strong>in</strong>ogenicity.<br />

Food <strong>and</strong> Drug Adm<strong>in</strong>istration

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