等价(形式语言)
排名(信息检索)
计算机科学
相似性(几何)
生物仿制药
数据挖掘
背景(考古学)
质量(理念)
产品(数学)
机器学习
人工智能
数学
医学
离散数学
内科学
哲学
古生物学
图像(数学)
认识论
生物
几何学
作者
Yi Tsong,Xiaoyu Dong,Meiyu Shen
标识
DOI:10.1080/10543406.2016.1272606
摘要
To evaluate the analytical similarity between the proposed biosimilar product and the US-licensed reference product, a working group at Food and Drug Administration (FDA) developed a tiered approach. This proposed tiered approach starts with a criticality determination of quality attributes (QAs) based on risk ranking of their potential impact on product quality and the clinical outcomes. Those QAs characterize biological products in terms of structural, physicochemical, and functional properties. Correspondingly, we propose three tiers of statistical approaches based on the levels of stringency in requirements. The three tiers of statistical approaches will be applied to QAs based on the criticality ranking and other factors. In this article, we discuss the statistical methods applicable to the three tiers of QA. We further provide more details for the proposed equivalence test as the Tier 1 approach. We also provide some discussion on the statistical challenges of the proposed equivalence test in the context of analytical similarity assessment.
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