Mutagenesis, Environmental

In experiments studying the effects of environmental stimuli on biological organisms, data are analyzed via various statistical approaches. Each of these depends on the nature of the biological endpoint and aspects of the particular assay under study. Among major endpoints of interest, damage to genetic components such as deoxyribonucleic acid (DNA) is of increasing interest. Mutagenesis is perhaps the most varied of any toxicological endpoint, since the potential mechanisms of genetic damage are so numerous. Statistical issues associated with mutagenicity experiments include construction of models to characterize dose response and other features of genetic damage, sample size determinations/study design, and the selection of statistical approaches associated with these models and methods.