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体外溶出度曲线比较——相似性因子f2的统计与分析

In vitro dissolution profile comparison--statistics and analysis of the similarity factor, f2.

作者信息

Shah V P, Tsong Y, Sathe P, Liu J P

机构信息

Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA.

出版信息

Pharm Res. 1998 Jun;15(6):889-96. doi: 10.1023/a:1011976615750.

DOI:10.1023/a:1011976615750
PMID:9647355
Abstract

PURPOSE

To describe the properties of the similarity factor (f2) as a measure for assessing the similarity of two dissolution profiles. Discuss the statistical properties of the estimate based on sample means.

METHODS

The f2 metrics and the decision rule is evaluated using examples of dissolution profiles. The confidence interval is calculated using bootstrapping method. The bias of the estimate using sample mean dissolution is evaluated.

RESULTS

  1. f2 values were found to be sensitive to number of sample points, after the dissolution plateau has been reached. 2. The statistical evaluation of f2 could be made using 90% confidence interval approach. 3. The statistical distribution of f2 metrics could be simulated using 'Bootstrap' method. A relatively robust distribution could be obtained after more than 500 'Bootstraps'. 4. A statistical 'bias correction' was found to reduce the bias.

CONCLUSIONS

The similarity factor f2 is a simple measure for the comparison of two dissolution profiles. But the commonly used similarity factor estimate f2 is a biased and conservative estimate of f2. The bootstrap approach is a useful tool to simulate the confidence interval.

摘要

目的

描述相似因子（f2）作为评估两种溶出曲线相似性的指标的特性。讨论基于样本均值的估计的统计特性。

方法

使用溶出曲线示例评估f2指标和决策规则。使用自助法计算置信区间。评估使用样本平均溶出度的估计偏差。

结果

  1. 发现f2值在达到溶出平台期后对样本点数敏感。2. 可使用90%置信区间方法对f2进行统计评估。3. 可使用“自助法”模拟f2指标的统计分布。经过500多次“自助抽样”后可获得相对稳健的分布。4. 发现统计“偏差校正”可减少偏差。

结论

相似因子f2是比较两种溶出曲线的简单指标。但常用的相似因子估计值f2是f2的有偏且保守的估计。自助法是模拟置信区间的有用工具。

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2
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J Pharm Sci. 1997 Jun;86(6):690-700. doi: 10.1021/js960473x.
3
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