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剂量反应研究。II. 分析与解读。

Dose response studies. II. Analysis and interpretation.

作者信息

Ruberg S J

机构信息

Marion Merrell Dow Inc., Kansas City, Missouri 64134-0627, USA.

出版信息

J Biopharm Stat. 1995 Mar;5(1):15-42. doi: 10.1080/10543409508835097.

Abstract

The primary focus of this paper is to examine analysis strategies for parallel, randomized dose response studies with particular emphasis on identifying the minimum effective dose. Such studies have become a standard for drug development in the pharmaceutical industry. Particular attention is paid to ANOVA followed by multiple comparison procedures with some additional discussion of the utility or regression models. When there are three or fewer dose groups and a placebo in a study, ANOVA techniques are preferred; with a larger number of dose groups, regression analysis has greater utility and reliability. Analysis of factorial dose response studies is reviewed only slightly as this is an emerging area of interest, and further development is necessary.

摘要

本文的主要重点是研究平行随机剂量反应研究的分析策略,特别强调确定最小有效剂量。此类研究已成为制药行业药物开发的标准。本文特别关注方差分析(ANOVA)以及随后的多重比较程序,并对效用或回归模型进行了一些额外讨论。当研究中有三个或更少的剂量组和一个安慰剂时,方差分析技术是首选;当剂量组数量较多时,回归分析具有更大的效用和可靠性。析因剂量反应研究的分析仅略有涉及,因为这是一个新兴的研究领域,还需要进一步发展。

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