Fell P J, Stevens M T
Eur J Clin Pharmacol. 1975 Apr 4;8(3-4):241-8. doi: 10.1007/BF00567122.
It is apparent from studying recent articles on pharmacokinetics that a number of misunderstandings exist, both about the design of experiments and the analysis of results. The purpose of this paper is to outline many of the common pitfalls associated with the design of experiments and also the limitations upon the analysis of results. The paper describes mathematical, laboratory and clinical aspects which must be examined in designing a protocol for pharmacokinetic experiments. Simulated data is presented to demonstrate the dangers of using standard computer programs for parameter estimation. Even when convergence is obtained the answers may be dependent on the method employed. A mathematical model is of little use unless a reasonable amount of good, accurate data is obtained.
从近期关于药代动力学的文章研究中可以明显看出，在实验设计和结果分析方面存在一些误解。本文的目的是概述与实验设计相关的许多常见陷阱以及结果分析的局限性。本文描述了在设计药代动力学实验方案时必须考虑的数学、实验室和临床方面。通过模拟数据展示了使用标准计算机程序进行参数估计的风险。即使获得了收敛结果，答案也可能取决于所采用的方法。除非获得合理数量的良好、准确的数据，否则数学模型用处不大。
