目的: 探讨生物效价结果表示的科学规范性。方法: 从方法的适用性、报告值的规范性、有效数字修约等方面来进行论述。结果: (1)只有当生物活性检测方法同时满足了系统适用性检验与样品适用性检验,才能得到准确可靠的最终报告值。(2)报告值的表示应体现相应的精密度,一般采用所测效价值的相对置信区间来表示。(3)报告值表示需依据方法的变异度确定有效数字的位数,并遵循相关修约规则。结论: 生物效价报告值表示的科学规范性探讨,对于效价测定具有示范作用。
Objective: To discuss the scientific standardization of the expression of biological potency results. Methods: The suitability assessment, the standardization of the reportable value and the modification of the significant figure were discussed. Results: (1)Accurate and reliable final report value could be obtained only when both system suitability test and sample suitability test of the bioassay was satisfied. (2)The expression of the reportable value should reflect the corresponding precision, usually expressed by using the relative confidence interval of the estimated potency. (3)The significant figure of the reportable value should be determined according to the variability of the bioassay and the relevant modification rules. Conclusion: The discussion on the scientific and standardized expression for reportable value of biological potency has a demonstration effect on titer determination.
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