In vitro dissolution profile comparison |
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In vitro dissolution profile comparison
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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.
中文翻译：
目的：描述相似性因子（f2）的性质，作为评估两个溶出曲线相似性的量度。讨论基于样本均值的估计值的统计属性。方法：使用溶出曲线实例评估f2指标和决策规则。置信区间是使用自举法计算的。使用样品平均溶出度估算的偏倚进行评估。结果：1.在达到溶解平台后，发现f2值对样品点数敏感。2.可以使用90％置信区间方法对f2进行统计评估。3.可以使用“ Bootstrap”方法模拟f2指标的统计分布。在超过500个“ Bootstraps”之后，可以获得相对健壮的分布。4，发现统计上的“偏差校正”可减少偏差。结论相似因子f2是比较两个溶出曲线的一种简单方法。但是，常用的相似性因子估计f2是f2的有偏和保守估计。引导程序方法是模拟置信区间的有用工具。 |
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