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ToxSci Advance Access originally published online on March 15, 2007
Toxicological Sciences 2007 98(1):39-42; doi:10.1093/toxsci/kfm056
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© The Author 2007. Published by Oxford University Press on behalf of the Society of Toxicology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Genetic Toxicity Assessment: Employing the Best Science for Human Safety Evaluation Part IV: A Strategy in Genotoxicity Testing in Drug Development: Some Examples

Elisabeth Lorge*,1, Véronique Gervais*, Nathalie Becourt-Lhote*, Catherine Maisonneuve*, Jean-Luc Delongeas* and Nancy Claude{dagger}

* Servier Group, Drug Safety Assessment, 45403 Orléans-Gidy, France {dagger} Servier Group, Institut de Recherches Internationales Servier, 92400 Courbevoie, France

1 To whom correspondence should be addressed at Biologie Servier BP 43255, 45403 Fleury-les-Aubrais, France. Fax: +33 2 38 23 86 50. E-mail: elisabeth.lorge{at}fr.netgrs.com.

Received January 25, 2007; accepted March 7, 2007


  Abstract

The minimal three-test battery of the International Conference on Harmonization guideline has been in use since 1997 for the development of new pharmaceuticals (ICH, 1997). After a 10-year experience of this core battery in regulatory genotoxicity testing, everywhere the time has come for reflection about what was learned from this experience. Different aspects of genotoxicity testing are currently being debated under different organizations (HESI, 2006; IWGT, 2007; Kirkland et al., 2007). The main concerns are to develop relevant strategies and adequate complementary tests to the minimal battery, appropriate for each specific case to assess risk for humans when in vitro positive results or findings in rodent bioassays for carcinogenicity are found. In this article, an example of an in-house decision tree is shown, with some options which can contribute to the current reflections. Additionally, tools built for early genotoxicity are presented.

Key Words: drug safety; genotoxicity strategy; genotoxicity battery.


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