Regulation of impurities in drug substances and products
Regulation of impurities in drug substances and products
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