Abstract：
During the drug development process, testing potency plays an important role in the quality assessment required for the manufacturing and marketing of biologics. Due to multiple operational and biological factors, higher variability is usually observed in bioassays compared with physicochemical methods. In this paper, we discuss different sources of bioassay variability and how this variability can be statistically estimated. In addition, we propose an algorithm to estimate the variability of reportable results associated with different numbers of runs and their corresponding OOS rates under a given specification. Numerical experiments are conducted on multiple assay formats to elucidate the empirical distribution of bioassay variability.
摘要：
在药物开发过程中,效价测试在生物制品生产和销售所需的质量评估中起着重要作用。由于多种操作和生物学因素，与物理化学方法相比，在生物测定中通常观察到更高的变异性。在本文中,我们讨论了生物测定变异性的不同来源，以及如何统计估计这种变异性。此外,我们提出了一种算法来估计在给定规范下与不同运行次数及其相应的OOS率相关的可报告结果的可变性。在多种测定格式上进行数值实验，以阐明生物测定变异性的经验分布。
