No Observed Adverse Effect Level (NOAEL)
NOAELThe highest dose in preclinical studies at which no statistically significant adverse effects are observed. Used to calculate the human equivalent dose and starting dose for first-in-human trials.
例
- NOAEL / safety factor = starting dose
- 90-day rat toxicology study
- Species-specific NOAEL
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The highest dose in preclinical studies at which no statistically significant adverse effects are observed. Used to calculate the human equivalent dose and starting dose for first-in-human trials.