符合这些限制的评估准确度和精密度的其他方法可能也同样适用。
Other methods of assessing accuracy and precision that meet these limits may be equally acceptable.
对于杂质的定量分析,应使用以已知数量杂质增敏的样榀来评估准确度。
In the case of quantitative analysis of impurities accuracy should be assessed on samples (of drug substance or drug product) spiked with known amount of impurities.
考虑评估时效性——因为每一天情况和需求都可能发生显著变化,时效影响一项评估的准确度。
Consider the Timing of the AssessmentTiming may affect the accuracy of an assessment because situations and needs can change dramatically from day to day.
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