Genetic toxicity assessment: employing the best science for human safety evaluation part IV: a strategy in genotoxicity testing in drug development: some examples.
Toxicol Sci
; 98(1): 39-42, 2007 Jul.
Article
em En
| MEDLINE
| ID: mdl-17369197
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.
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Base de dados:
MEDLINE
Assunto principal:
Preparações Farmacêuticas
/
Testes de Mutagenicidade
/
Mutagênicos
Tipo de estudo:
Prognostic_studies
Limite:
Animals
/
Humans
Idioma:
En
Ano de publicação:
2007
Tipo de documento:
Article