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期刊名称：药物分析杂志
主管单位：中国科学技术协会
主办单位：中国药学会承办：中国食品药品检定研究院
主编：金少鸿
地址：北京天坛西里2号
邮政编码：100050
电话：010-67012819,67058427 电子邮箱：ywfx@nifdc.org.cn
国际标准刊号：ISSN 0254-1793
国内统一刊号：CN 11-2224/R
邮发代号：2-237
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相对差异基础上的生物相似性评估标准
A criterion of assessing biosimilarity based-on the relative difference
单位：1. School of Sciences, Communication University of China, Beijing 100024, China;
2. School of Medicine, Duke University, Durham, NC, 27705, USA;
3. College of Applied Sciences, Beijing University of Technology, Beijing 100124, China
单位(英文)：1. School of Sciences, Communication University of China, Beijing 100024, China;
2. School of Medicine, Duke University, Durham, NC, 27705, USA;
3. College of Applied Sciences, Beijing University of Technology, Beijing 100124, China
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：-------------------------------------------------------------------------------------------
为了检测仿制生物制品与其原研生物制品的相似性,目前主要采用基于相对差异指标的统计方法进行评价。常用的统计推断主要基于双序列(two-sequence)、双周期(two-period)的交叉设计,或者在忽略原研药批次间变异情况下的双臂平行设计。本文采用三臂平行设计(three-arm parallel design),分别测定仿制生物制品与原研生物制品的绝对差异,原研生物制品不同批次间的绝对差异,并通过该两绝对差异之比来评价仿制生物制品与原研生物制品的生物相似性概率(biosimilar probability)。这种基于生物相似性概率的评价标准,在大样本下具有渐进正态的性质,给出了检验的功效和临床试验中样本量的计算公式。本文通过模拟研究和样本量估算,证明了生物相似性概率的统计检验法具有良好的检验效能。
-----英文摘要：---------------------------------------------------------------------------------------
Currently for the sake of testing biosimilarity between an innovative biological drug product and a follow-on biologics, some statistical methods are considered based on the relative distance criteria, commonly statistical inferences under a two-sequence, two-period(2×2)crossover design or a two-arm parallel design ignoring the variability of the innovative products among different batches.In this article we consider to assess the biosimilarity between a biosimilar product and an innovative biological drug product under the three-arm parallel design, one absolute difference from the biosimilars and the innovative biological drug product, the other between the two innovative products from different batches.The statistical test is developed based on biosimilar probability, the new criterion of assessing biosimilarity displayed the good asymptotic properties under large sample size, the test power and the calculation of sample size are obtained.By the simulation the good performance of the proposed assessing method is shown.
-----参考文献：---------------------------------------------------------------------------------------
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