Abstract
The trough/peak ratio, the ratio of mean trough effect to mean peak effect, has been recently proposed as a measure for evaluating sustained release formulations of antihypertensive medications. This paper gives a method for constructing exact confidence intervals for the true trough/peak ratio of parallel, placebo–controlled, clinical trials. The confidence interval procedure, which can also be used to test hypotheses about the trough/peak ratio, is based on a transformation from bivariate to univariate responses. Moreover, it can be shown that this method is identical to an extension of Fieller's method of confidence interval construction. The method is demonstrated with data from a clinical trial which compared an antihypertensive agent to placebo.
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