相對差異基礎(chǔ)上的生物相似性評估標準（英文）
發(fā)布時間：2018-11-07 14:38
【摘要】：為了檢測仿制生物制品與其原研生物制品的相似性,目前主要采用基于相對差異指標的統(tǒng)計方法進行評價。常用的統(tǒng)計推斷主要基于雙序列(two-sequence)、雙周期(two-period)的交叉設(shè)計,或者在忽略原研藥批次間變異情況下的雙臂平行設(shè)計。本文采用三臂平行設(shè)計(three-arm parallel design),分別測定仿制生物制品與原研生物制品的絕對差異,原研生物制品不同批次間的絕對差異,并通過該兩絕對差異之比來評價仿制生物制品與原研生物制品的生物相似性概率(biosimilar probability)。這種基于生物相似性概率的評價標準,在大樣本下具有漸進正態(tài)的性質(zhì),給出了檢驗的功效和臨床試驗中樣本量的計算公式。本文通過模擬研究和樣本量估算,證明了生物相似性概率的統(tǒng)計檢驗法具有良好的檢驗效能。
[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.
【作者單位】： School
【分類號】：R927.1
本文編號：2316669
[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.
【作者單位】： School
【分類號】：R927.1
【共引文獻】
相關(guān)期刊論文 前1條
1 Tsung-cheng Hsieh;Shein-chung Chow;;生物類似藥證據(jù)鏈完備性的隨機系數(shù)回歸分析法評估（英文）[J];藥物分析雜志;2015年05期
相關(guān)博士學位論文 前1條
1 呂穎;臨床試驗中橋接研究和生物相似性研究的統(tǒng)計推斷[D];北京工業(yè)大學;2014年
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