Genotoxicity testing guidelines

Overview of In Vivo Mutagenicity/Genotoxicity Test Guideline Studies... 

As performance data has become available on these strains, ICH (1997) has incorporated their use into pharmaceutical testing guidelines in lieu of the second rodent species tests (that is, to replace the long-term mouse bioassay when the traditional rat study has been performed). FDA has stated that they would accept such studies when performed in a validated model. In fact, CBER has accepted such studies as a sole carcinogenicity bioassay in some cases where there was negative traditional genotoxicity data and strong evidence of a lack of a mechanistic basis for concern. 

In the various OECD test guidelines for mutagenicity/genotoxicity testing, the definitions relevant for a specific test are provided in the Annex. 

The OECD, US-EPA, and EU have developed a number of specific test guidelines for in vitro testing of mutagenicity/genotoxicity, see Table 4.15. The EU Annex V methods are generally... 

Test Guidelines Adopted for In Vivo Testing of Mutagenicity/Genotoxicity... 

An in vivo test for chromosomal damage using rodent haematopoietic cells. ICH guideline, Genotoxicity A Standard Battery for Genotoxicity Testing of Pharmaceuticals ... 

The current ICH harmonized tripartite guideline for genotoxicity testing of pharmaceuticals (S2B) defines a standard battery of tests, including both in vitro... 

ICH Harmonised Tripartite Guideline (S2A). Guidance on specific aspects of regulatory genotoxicity tests for pharmaceuticals. July 19, 1995. 

ICH Harmonised Tripartite Guideline (S2B). Genotoxicity A standard battery for genotoxicity testing of pharmaceuticals. July 16, 1997. 

Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals ICH Harmonized Tripartite Guideline (S2A), 1995. 

The new guidelines are based on ICH guidelines on specific aspects of regulatory genotoxicity studies S2A and a standard battery for genotoxicity testing S2B. 

ICH guideline Genotoxicity A Standard Battery for Genotoxicity Testing of Pharmaceuticals. 

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