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Regulation of impurities in drug substances and products

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Steps <strong>in</strong> any Risk Assessment<br />

Dose Dose-Response Dose Dose-Response Response Assessment<br />

Assessment<br />

how does the frequency <strong>of</strong> the<br />

adverse event change with<br />

exposure? ?<br />

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

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