生物类似药证据链完备性的随机系数回归分析法评估（英文）

发布时间：2018-07-08 10:39

本文选题：证据链完备性 + 通用相似性　；参考：《药物分析杂志》2015年05期

【摘要】：由于生物制品具有复杂的特征和性质,为评估申请者的生物相似性证据,美国FDA建议使用"基于风险"和"证据链完备性"(totality-of-the-evidence)的方式来评估已递交的全部特征域间的所有可用数据和信息。因此,需要建立一个生物类似性指数,使该指数能将各个具体特征域中的生物相似性整合成为一个跨指标领域的总体指数(global index)。Shein-Chung Chow等人已经在2010年根据受试品-参考品(T-R)与参考品-参考品(R-R)比较研究中重现性概率(reproducibility probability)的概念,提出了一个评估相似性通用的方法,该方法可用于"证据链完备性"的评估。本文提出另外一个生物相似性评价指数,该指数基于配对随机设计下随机系数的线性回归模型,并提供了相应的统计检测步骤。文中用一个数值型实例对所提出的方法进行了证明。
[Abstract]:Because of the complex characteristics and nature of biological products, in order to assess the applicant's biological similarity evidence, The FDA recommends the use of "risk-based" and "evidence-chain completeness" (totality-of-the-evidence) methods to evaluate all available data and information between all submitted feature domains. So there is a need for a biological similarity index, (global index). Shein-Chung Chow et al., which enables the index to integrate biological similarity across specific feature domains into a cross-index domain, have been based on a comparative study of test-take-reference (T-R) and reference-reference (R-R) studies in 2010. The concept of reproducibility probability (reproducibility probability), A general method for evaluating similarity is presented, which can be used to evaluate the completeness of evidence chain. In this paper, another biological similarity evaluation index is proposed, which is based on the linear regression model of random coefficients under pairwise random design, and provides the corresponding statistical detection steps. The proposed method is proved by a numerical example.
【作者单位】： Institute
【分类号】：R91

【共引文献】