Reporting, identification and qualification thresholds

ICH Q3B(R2) levels, set by maximum daily dose, above which a degradation product must be reported, identified (structure determined) and qualified (shown to be safe). For doses above 2 g/day they are 0.05%, 0.10% and 0.15%.

• Also: ICH Q3B thresholds
• Also: reporting threshold
• Also: identification threshold
• Also: qualification threshold