相对差异基础上的生物相似性评估标准（英文）

发布时间：2018-11-07 14:38

【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。
[Abstract]:In order to detect the similarity between imitating biological products and their original biological products, the statistical methods based on relative difference indexes are mainly used to evaluate them. The commonly used statistical inference is mainly based on the cross design of two-sequence, two-period, or the parallel design of two arms without the variation of the original batch. In this paper, three arm parallel design (three-arm parallel design),) is used to measure the absolute difference between biological-imitating products and original bioproducts, and the absolute differences among batches of protoproducts. The probability of biological similarity between bionic and original biological products was evaluated by the ratio of these two absolute differences. The evaluation criteria based on the probability of biological similarity have the properties of progressive normality in large samples. The efficacy of the test and the calculation formula of sample size in clinical trials are given. In this paper, the statistical test method of biological similarity probability is proved to be effective by simulation and sample size estimation.
【作者单位】： School
【分类号】：R927.1

【共引文献】