Chapter 4

Evaluation of mutagenicity assays

4.1 What is specific in the analysis of mutagenicity assays?

It is no coincidence that the most cited work in the last few years refers to the Comet assay [247]. Yes, the various in vitro and in vivo mutagenicity bioassays make substantial demands on the statistical method. Selected issues are formulated in the following 12 special features:

  1. The concentrations used particularly in in vitro assays are somewhat arbitrary in relation to the exposure to humans. Therefore, a tendency to overdosing exists to avoid false negative results. A specific dose-response problem may occur: downturn effects at high(er) concentrations. Trend tests assuming strict order restriction may be seriously biased and therefore ...

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