生物类似药证据链完备性的随机系数回归分析法评估
Assessment of totality-of-the-evidence of biosimilar products using regression analysis with random coefficients
分类号：
出版年·卷·期（页码）：2015,35 (5):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----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。
-----英文摘要：---------------------------------------------------------------------------------------
As the complexity of characteristics and nature of biologic products, for evaluating a sponsor's demonstration of biosimilarity, the United States Food and Drug Administration(FDA)suggests using a risk-based, totality -of-the-evidence approach to evaluate all available data and information submitted in support of the regulatory submission across different domains.Thus, the development of a biosimilarity index which can integrate local biosimilarity in each specific domain into the global index across domains is required.Shein-Chung Chow et al.proposed a general approach for assessing biosimilarity based on the concept of the reproducibility probability in a T-R study as compared to that of an R-R study, which can be used for assessing totality-of-the-evidence.In this article, an alternative biosimilar index based on linear regression model with random coefficients under a paired-randomized design and corresponding statistical testing procedures are proposed.A numeric example is provided to illustrate the proposed methods.
-----参考文献：---------------------------------------------------------------------------------------
[1] FOX A.Biosimilar medicines—New challenges for new class of medicine[J].J Biopharm Stat, 2010, 20(1):1
[2] CHOW SC, LIU JP.Statistical assessment of biosimilar products[J].J Biopharm Stat, 2010, 20(1):10
[3] FDA.Scientific considerations in demonstrating biosimilarity to a reference product[S].2012
[4] FDA.Quality considerations in demonstrating biosimilarity to a reference protein product[S].2012
[5] FDA.Biosimilars:Questions and answers regarding implementation of the Biologics Price Competition and Innovation Act of 2009[S].2012
[6] CHOW SC, HSIEH TC CHI E, et al.A comparison of moment-based and probability-based criteria for assessment of follow-on biologics[J].J Biopharm Stat, 2010, 20(1):31
[7] HSIEH TC, CHOW SC, YANG LY, et al.The evaluation of biosimilarity index based on reproducibility probability for assessing follow-on biologics[J].Stat Med, 2013, 32(3):406
[8] Efron B, Tibshirani RJ.An Introduction to the Bootstrap[M].New York:Chapman & Hall/CRC., 1993
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