Presentation on M7 - ICH
Presentation on M7 - ICH
Presentation on M7 - ICH
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<strong>ICH</strong> <strong>M7</strong> Guideline <strong>on</strong> Mutagenic Impurities<br />
Draft <strong>ICH</strong> <strong>M7</strong> Guideline Title<br />
• Assessment and C<strong>on</strong>trol of DNA Reactive (Mutagenic)<br />
Impurities in Pharmaceuticals to Limit Potential<br />
Carcinogenic Risk<br />
o Objective was to place focus <strong>on</strong> limiting carcinogenic risk of<br />
low level DNA-reactive mutagenic impurities<br />
© 2011 <strong>ICH</strong> 9
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