The OECD Guidelines for the Testing of Chemicals are of fundamental importance for the evaluation of both chemicals and pharmaceuticals. Recently, several OECD Guidelines for genotoxicity testing like OECD 473 (Mammalian Erythrocyte Micronucleus Test), OECD 489 (In Vivo Mammalian Alkaline Comet Assay), OECD 474 (In Vitro Mammalian Chromosomal Aberration Test) and OECD 487 (In Vitro Mammalian Cell Micronucleus Test) were updated, and statistical issues were now given a central role in data evaluation. However, detailed recommendations for an appropriate statistical methodology regarding design, analysis and interpretation of results are often missing. The resulting uncertainty motivated the formation of the working group "Statistics" within the "Gesellschaft für Umwelt-Mutationsforschung e.V." (GUM) in winter 2015/16. This working group is composed of genotoxicologists and statisticians from industry, contract research organizations, and regulatory bodies. The working group "Statistics" thereby serves as a forum to discuss and develop strategies for statistical data analysis in genotoxicity testing. In this talk we will briefly present our working group strategies, initial goals, achievements to date as well as future topics of our collaboration. Furthermore, we will show in more detail results from our current activities, e.g. the evaluation of statistical issues regarding the in vivo micronucleus tests in rats. This includes, among other things, the collection and "cleaning" of corresponding historical control data from different labs as well as the specification of distributions, relevant stratification parameters, and tolerance intervals.
Hier finden Sie weitere Informationen und das Programm des EEMGS 2018.