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FAQs

This FAQs section details frequently asked questions about the ICH M7 guidelines. For FAQs on Lhasa products, please refer to the relevant product area.
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What do the ICH M7 guidelines mean for me?
  • SAR methodologies can be used to support decision making of the mutagenic potential of impurities, thereby minimising the expense of testing.
  • You can make use of existing data to support your decisions and submissions.
  • Regulatory agencies will accept results from (Q)SAR methodologies in lieu of in vitro testing.
  • Expert review will allow you to justify your case.
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