USP〈1225〉药典规程的验证(中英文对照)(6)

with confidence interval.

通过测定被加入到样品中的已知数量的被分析物来计算准确度，得到回收百分比，或得到平均值与接受的真实值之间的差异，并给出置信区间。

The ICH documents recommended that accuracy should be assessed using a minimum of nine determinations over a minimum of three concentration levels, covering the specified range (i.e., three concentrations and three replicates of each concentration).

ICH文件建议精密度的评估应当使用覆盖规定范围的至少三个浓度水平进行至少九次测试（例如，三个浓度并且每个浓度三次重复进样）。

Assessment of accuracy can be accomplished in a variety of ways, including evaluating the recovery of the analyte (percent recovery) across the range of the assay, or evaluating the linearity of the relationship between estimated and actual concentrations. The statistically preferred criterion is that the confidence interval for the slope be contained in an interval around 1.0, or alternatively, that the slope be close to 1.0. In either case, the interval or the definition of closeness should be specified in the validation protocol. The acceptance criterion will depend on the assay and its variability and on the product. Setting an acceptance criterion based on the lack of statistical significance of the test of the null hypothesis that the slop is 1.0 is not an acceptable approach.

准确度的评估可以通过多种不同的方式完成，包括评价在含量测定的整个范围内被分析物的回收率，或评价估计与实际浓度之间关系的线性。具统计学意义的标准有二，一是斜率的置信区间被限定在约1.0的区间，二是此斜率接近1.0。在任意一种情况下，此区间或接近程度的定义应该在验证方案中明确规定。接受标准将取决于含量和其差异性，以及取决于该产品。通过测试证明该斜率为1.0的零假设没有统计学意义，这样的方法不能用于设定接受标准。

PRECISION精密度

Definition---- The precision of an analytical procedure is the degree of agreement among individual test results when the procedure is applied separately to multiple samplings of a homogeneous sample. The precision of an analytical procedure is usually expressed as the standard deviation or relative standard deviation (coefficient of variation) of a series of measurements. Precision may be a measure

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