Modifications of the closure principle for analyzing toxicological studies

Abstract

A Drug Information Association Workshop on “Statistical Methodology on Non-Clinical and Toxicological Studies” was held on March, 25-27, 1996. The purpose of this meeting was to discuss the appropriateness of current and new biostatistical methods in this field of drug development. This paper proposes a simple closure test for dose-response relationships under real data conditions. This approach takes into account deviation from variance homogeneity and monotonicity assumptions. Moreover, this approach can be easily adapted for “any” kind of two-sample tests, for example, nonparametric, dichotomous, censored, and so forth. Power was compared by a simulation study for selected conditions. © 1997, Drug Information Association. All rights reserved.