genotoxicity
- Guideline or reference source
- ICHM7 Assessment and control of dna reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
- ICHS2 Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use
- Definition
- A broad term that refers to any deleterious change in the genetic material regardless of the mechanism by which the change is induced.
- Related Term
- clastogen
- genotoxic carcinogens
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