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Application Principles ICH M7 Guideline Calculation ...
The ICH M7 guideline discusses the derivation of acceptable intakes for mutagenic impurities with positive carcinogenicity data, (section 7.2.1) and sta tes: “Compound-specific risk assessments to derive acceptable intakes should be applied instead of the TTC -based [Threshold of Toxicological
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Q12 Step 2b Technical and regulatory …
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pqri.org–mutagenic concerns (ICH M7) 3. Inappropriate qualification thresholds: – ICH Q3A and Q3B thresholds are not appropriate for E/Ls! – Cramer Thresholds alone are not appropriate – lack of transparency 4. Inadequate stability data to examine trends in leachables over time 5. Inadequate toxicology justification to support PDE assessment 6.