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一个案例研究,用于使用等价性测试方法对联体结合试验的关键反应物资格

Nancy A Niemuth¹, Cheryl A Triplett², Michael S Anderson²

¹Battelle Health Analytics, Columbus, OH, USA. niemuth616@gmail.com.

The AAPS journal

|September 15, 2023

概括

关键试剂资格在配体结合试验可以使用等效性测试. 功率分析显示,12个板块/批量与1.5σ边界支持强大的资格,特别是可变测试.

科学领域:

生物制药学分析分析
测试的开发和验证.
统计质量控制统计质量控制

背景情况:

监管机构建议对关键试剂批量进行并行测试,以进行配体结合测试.
对试验设计的试剂资格存在有限的指导.

研究的目的:

通过同等性测试,提出一种统计学上合理的临界试剂合格方法.
为设计试剂合格实验提供功率分析.

主要方法:

对于等效区域 (1.25至1.5倍的GM比率) 的功率分析.
对合格实验进行模拟分析 (6,12或18个板/批).
测试变量的评估 (5%至30%CV).

主要成果:

一个1.25倍等效区域需要6-12个盘子,测量高达15%的CV.
如果控制漂移,更广泛的等效区域适用于更可变的测定.
12个有1.5σ边界的板块/批量提供90%的功率,与生物相似属性测试保持一致.

结论:

相当性测试是关键试剂合格的统计学有效方法.
实验设计应考虑试验的可变性和所需的等效区域.
拟议的方法支持在配体结合试验中对关键试剂进行可靠的合格.

关键词:

临界试剂资格认证临界试剂资格认证相当区域的地区等价区.同等性测试等同性测试权力,权力,权力,权力.样本的大小样本大小

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