Kringle R O
Sterling Winthrop Pharmaceuticals Research Division, Collegeville, Pennsylvania 19426-0900.
Pharm Res. 1994 Apr;11(4):556-60. doi: 10.1023/a:1018922701174.
A recent conference report described a decision rule, hereafter referred to as the 4-6-20 rule, for acceptance/rejection of analytical runs in bioavailability, bioequivalence, and pharmacokinetic studies. This procedure requires that quality control specimens at three concentrations (low, medium, and high) be assayed in duplicate in each run. For run acceptance, at least four of the six assay values must be within +/- 20% of their respective nominal concentrations, and at least one of the two values at each concentration must be within these limits. An inherent flaw in this decision rule is that the risk of rejecting runs, when the assay performance has in fact not deteriorated, varies for each assay and is neither known nor controlled. In this paper simulation methods are used to evaluate the operating characteristics of the 4-6-20 rule in comparison to those of classical statistical quality control procedures.
最近的一份会议报告描述了一种用于生物利用度、生物等效性和药代动力学研究中分析批次接受/拒绝的决策规则，以下简称4-6-20规则。该程序要求在每次运行中对三种浓度（低、中、高）的质量控制样本进行双份测定。对于批次接受，六个测定值中至少有四个必须在其各自标称浓度的±20%范围内，并且每个浓度的两个值中至少有一个必须在这些范围内。该决策规则的一个固有缺陷是，当分析性能实际上并未恶化时，拒绝批次的风险因每次分析而异，既未知也无法控制。在本文中，使用模拟方法来评估4-6-20规则与经典统计质量控制程序相比的操作特性。
