Biostatistical analysis of the micronucleus mutagenicity assay based on the assumption of a mixing distribution.

The in vivo micronucleus assay can be analyzed by comparing the number of micronuclei (MN) of several dose groups with those of a control group. In several publications, difficulties arose in estimating a suitable distribution for MN, even in the untreated historical control groups. Mitchell et al. described the presence of a subpopulation of more susceptible responders. Based on this assumption of such a subpopulation, score tests were used for the mixing distribution of responders and nonresponders (behavior same as in untreated control animals) within the dose groups. The power behavior of these tests was characterized with a simulation study. The advantage of score tests can be shown, even in the practical and important guideline case of only five animals per group.