Abstract

In potency assays, the relative potency (RP) is the measure of the biological activity of a test product relative to a reference standard. It is calculated as the horizontal difference between the log(concentration)–response curves of each product. Parallelism (or similarity) between those curves is required for the RP to be meaningful. The literature proposes equivalence tests for similarity, based on the ratio of the curve parameters. Deriving equivalence margins (or a zone of declared similarity) to avoid rejecting good curves (lab risk) or accepting bad curves (consumer risk) often requires historical data. In this article, we propose a three-step derivation of the similarity zone to control for both consumer and lab risk, even when historical data are not available. In addition, we propose a way to test for parallelism that accounts for the correlations among the ratios of curve parameter estimates.

摘要

在效力测定中，相对效力 (RP) 是测试产品相对于参考标准的生物活性的量度。它计算为每种产品的对数（浓度）-响应曲线之间的水平差异。要使 RP 有意义，这些曲线之间的平行性（或相似性）是必要的。文献提出了基于曲线参数比率的相似性等价检验。推导等效边际（或声明的相似区域）以避免拒绝良好曲线（实验室风险）或接受不良曲线（消费者风险）通常需要历史数据。在本文中，我们提出了相似区域的三步推导，以控制消费者和实验室风险，即使在历史数据不可用时也是如此。此外，