GlaxoSmithKline Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2NY, UK.
Anal Chem. 2009 Dec 15;81(24):9841-8. doi: 10.1021/ac901944t.
Quality by design (ICH-Topic Q8) requires that process control strategy requirements are met and maintained. The challenging task of setting appropriate acceptance criteria for assessment of method equivalence is a critical component of satisfying these requirements. The use of these criteria will support changes made to methods across the product lifecycle. A method equivalence assessment is required when a change is made to a method which may pose a risk to its ability to monitor the quality of the process. Establishing appropriate acceptance criteria are a vital, but not clearly understood, prerequisite to deciding the appropriate design/sample size of the equivalency study. A number of approaches are proposed in the literature for setting acceptance criteria for equivalence which address different purposes. This perspective discusses those purposes and then provides more details on setting acceptance criteria based on patient and producer risk, e.g., tolerance interval approach and the consideration of method or process capability. Applying these to a drug substance assay method for batch release illustrates that, for the equivalence assessment to be meaningful, a clear understanding and appraisal of the control requirements of the method is needed. Rather than a single exact algorithm, the analyst's judgment on a number of aspects is required in deciding the appropriate acceptance criteria.
质量源于设计（ICH-Topic Q8）要求满足并维持过程控制策略要求。设定用于评估方法等效性的适当验收标准是满足这些要求的关键组成部分。这些标准的使用将支持在产品生命周期内对方法进行更改。当方法发生可能影响其监测过程质量能力的更改时，需要进行方法等效性评估。建立适当的验收标准是决定等效性研究的适当设计/样本量的重要但尚未被明确理解的前提条件。文献中提出了许多用于设定等效性验收标准的方法，这些方法针对不同的目的。本观点讨论了这些目的，然后详细介绍了基于患者和生产者风险的验收标准设定，例如，容忍区间方法和对方法或过程能力的考虑。将这些方法应用于药物含量测定方法的批放行，说明了为了使等效性评估有意义，需要对方法的控制要求有清晰的理解和评估。在决定适当的验收标准时，需要分析师在许多方面做出判断，而不是单一的精确算法。
