Statistical considerations for some studies of over-the-counter drugs

被引：1

作者：

Lin, Stan C. ^{[1
]}

机构：

[1] US FDA, Div Biometr 4, Off Biostat, Ctr Drug Evaluat & Res, Silver Spring, MD USA

来源：

DRUG INFORMATION JOURNAL | 2007年 / 41卷 / 04期

关键词：

over-the-counter drugs; label comprehension and actual use studies; confidence intervals; sample size; variance estimate;

D O I：

10.1177/009286150704100409

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

In this article, the label comprehension and actual use studies that may be required for an over-the-counter new drug regulatory submission are introduced. Design for these studies and statistical issues are described. Because confidence interval is a tool that plays a central role in these studies, information needed and appropriate sample size estimation approaches are discussed. Carefully designed and analyzed studies would enhance their success rate and provide more useful information from the studies.

引用

页码：511 / 516

页数：6

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