Notification, Identification, and Qualification Thresholds
| Maximum Daily Dose1 | Threshold1,2 | |
|---|---|---|
| Reporting | ≤1 g | 0.1% |
| >1 g | 0.05% | |
| Identification | <1 mg | 1.0% or 5 μg TDI, whichever is lower |
| 1–10 mg | 0.5% or 20 μg TDI, whichever is lower | |
| >10–2 g | 0.2% or 2 mg TDI, whichever is lower | |
| >2 g | 0.10% | |
| Qualification | <10 mg | 1.0% or 50 μg TDI, whichever is lower |
| 10–100 mg | 0.5% or 200 μg TDI, whichever is lower | |
| >100 mg to 2 g | 0.2% or 3 mg TDI, whichever is lower | |
| >2 g | 0.15% |
Source: ICH, 2006 (1).
↵1 The amount of drug administered per day.
↵2 Thresholds for degradation products are expressed either as a percentage of the drug or as total daily intake (TDI) of the degradation product. Lower thresholds may be appropriate if the degradation product is unusually toxic.
3Higher thresholds should be scientifically justified.