Potency determination via bioassay is a relative measure that requires an evaluation of parallelism between the dose–response relationships of a reference standard and a sample material. Typical approaches for assessing parallelism include difference ($p$-value) and equivalence tests. These traditional methods rely on a statistical assessment of model parameters as opposed to direct evaluation of the similarity of the dose–response curves. We propose a simple curve similarity approach that tests the hypothesis that the sample material is a dilution or concentration of the reference standard. The test is achieved by quantifying and normalizing the total area between the two curves and provides a single composite measure of parallelism. Both a frequentist and a Bayesian approach to the test are provided. We show through a simulation study that the curve similarity approach overcomes the drawbacks of the traditional methods and is effective at detecting parallelism and non-parallelism for bioassays.

通过生物测定进行的效价测定是一种相对测量，需要评估参考标准和样品材料的剂量-反应关系之间的平行性。评估并行性的典型方法包括差异（$磷$-value) 和等价测试。这些传统方法依赖于模型参数的统计评估，而不是直接评估剂量反应曲线的相似性。我们提出了一种简单的曲线相似性方法来检验样品材料是参考标准的稀释液或浓度的假设。该测试是通过对两条曲线之间的总面积进行量化和归一化来实现的，并提供了一个单一的平行度综合度量。提供了测试的频率论和贝叶斯方法。我们通过模拟研究表明，曲线相似性方法克服了传统方法的缺点，可有效检测生物测定的平行性和非平行性。