safety factor
- Guideline or reference source
- ICHQ3D Guideline for elemental impurities
- Definition
- A composite (reductive) factor applied by the risk assessment experts to the No-Observed-Adverse-Effect Level (NOAEL) or other reference point, such as the benchmark dose or benchmark dose lower confidence limit, to derive a reference dose that is considered safe or without appreciable risk, such as an acceptable daily intake or tolerable daily intake (the NOAEL or other reference point is divided by the safety factor to calculate the reference dose). The value of the safety factor depends on the nature of the toxic effect, the size and type of population to be protected, and the quality of the toxicological information available.
- Related Term
- acceptable intake
- no-observed-adverse-effect level
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