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杂质方法学研究 英文45

发布者: lorespirit | 发布时间: 2012-8-25 10:12| 查看数: 664| 评论数: 0|

Intermediate Precision.ICH definition: Intermediate precision expresses, within

laboratories variations, different days, different analysts, different equipment, and

so on.

Intermediate precision is to determine method precision in different experiments

using different analysts and/or instrument setup. Similar to that of repeatability,

oneshouldevaluate the resultsof individualrelated substances,total related

substances, and the consistency of related substance profiles in all experiments.

The percent RSD and confidence level of these results are reported to illustrate

the intermediate precision.

Reproducibility.ICH definition: Reproducibility expresses the precision between

laboratories(collaborativestudiesaregenerallyused,forstandardizationof

methodology).

This is an optional validation parameter that requires demonstration of laboratory-

to-laboratory variation only if multiple laboratories use the same procedure. The

reproducibility data can be obtained during method transfer between laboratories.

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