Timm U, Wall M, Dell D
J Pharm Sci. 1985 Sep;74(9):972-7. doi: 10.1002/jps.2600740913.
The purpose of this study was to develop a procedure for investigating the stability of drugs in biological fluids based on sound experimental design and to use a statistical procedure which would allow conclusions to be made concerning stability with an acceptable degree of certainty (95%). The experimental procedure involved replicate analysis of the drug in stored and freshly prepared samples on the same day. The relative difference in response between these two sets of samples and a 90% confidence interval for the true change in response was calculated. This confidence interval enabled us to detect a pharmacokinetically relevant degradation. It is argued that this approach is superior to the stability test procedures based on the t test. The application of the method to the assessment of the stability of three different drugs in biological fluids is described.
本研究的目的是基于合理的实验设计制定一种用于研究生物流体中药物稳定性的程序，并使用一种统计程序，该程序能够在可接受的确定程度（95%）下就稳定性得出结论。实验程序包括在同一天对储存样本和新制备样本中的药物进行重复分析。计算这两组样本之间响应的相对差异以及响应真实变化的90%置信区间。该置信区间使我们能够检测到具有药代动力学相关性的降解。有人认为，这种方法优于基于t检验的稳定性测试程序。描述了该方法在评估三种不同药物在生物流体中的稳定性方面的应用。
