title: Genetic toxicity assessment: employing the best science for human safety evaluation part IV: a strategy in genotoxicity testing in drug development: some examples.
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.
authors: Servier Group, Drug Safety Assessment, 45403 Orléans-Gidy, France. elisabeth.lorge@fr.netgrs.com
authors: Elisabeth
authors: E
authors: Lorge
authors: Véronique
authors: V
authors: Gervais
authors: Nathalie
authors: N
authors: Becourt-Lhote
authors: Catherine
authors: C
authors: Maisonneuve
authors: Jean-Luc
authors: JL
authors: Delongeas
authors: Nancy
authors: N
authors: Claude
mesh_terms: D000818:Animals; D006801:Humans; D009152:Mutagenicity Tests; D009153:Mutagens / Q000633:toxicity*; D004364:Pharmaceutical Preparations; D013723:Teratogens / Q000633:toxicity
chemical_list: D009153:Mutagens; D004364:Pharmaceutical Preparations; D013723:Teratogens