Tuesday 19th September 2017
2:00-3:00 pm (UK Time)
(Organised by the Toxicology Special Interest Group)
Presenter: David Lovell, St George’s Medical School, University of London
The bacterial reverse mutation assay (or the Ames test) has been in use in its present form for over 40 years. It is arguably the most successful in vitro test, used by hundreds of laboratories worldwide, on thousands of substances. The test aims to identify substances that can produce genetic damage and may lead to cancer in exposed individuals or to inherited mutation in offspring to cancer.
The design of the test is basically simple and numerous statistical tests have been proposed for the analysis of the data produced. Interpretation of the result aims at categorizing the chemical as either a genotoxin or a non-genotoxin. This provides an interesting example of the contrast between statistical significance and biological interpretation. Ames test results are also used in helping to develop in silico methods for predicting carcinogenicity.
This presentation will illustrate these issues and also discuss newer versions of the test and the continuing assessment of the role of the test in toxicology.
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on this topic to date.
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