基于国际人用药品注册技术协调会（ICH）质量指南Q2B对分析方法开发和常规质量控制中回收率范围的比较

Comparison of the recovery spread in analytical development and routine quality control--based on the ICH quality guideline Q2B.

作者信息

Schepers U, El Deeb S, Ermer J, Wätzig H

机构信息

Institute of Pharmaceutical Chemistry, TU Braunschweig, Beethovenstr. 55, 38106 Braunschweig, Germany.

出版信息

J Pharm Biomed Anal. 2007 Jan 17;43(2):708-10. doi: 10.1016/j.jpba.2006.07.012. Epub 2006 Aug 9.

DOI:10.1016/j.jpba.2006.07.012

PMID:16904281

Abstract

In the present study, a simulation was performed for the ICH Q2B guideline for assessing the accuracy. By means of an experimental data set a permutation has been performed to investigate in which interval experimental mean recovery can be expected to scatter just by random effects. A good agreement has been found between the experimental intervals obtained by means of a permutation and the statistically derived confidence intervals. These findings could be confirmed with additionally generated virtual data sets with a true mean of 100% and a true standard deviation of 0.7%.

摘要

在本研究中，针对评估准确性的ICH Q2B指南进行了模拟。借助一个实验数据集进行了排列，以研究仅通过随机效应实验平均回收率预期会在哪个区间内分散。通过排列获得的实验区间与统计得出的置信区间之间发现了良好的一致性。这些发现可以通过另外生成的真实均值为100%且真实标准差为0.7%的虚拟数据集得到证实。