Genotoxicity testing guidelines pharmaceuticals

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. 

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

The International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Htrman Use (ICH) guideline(s) for genotoxicity testing of pharmaceuticals... 

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. 

ICH (2008). Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use. ICH Harmonized Tripartite Guideline S2(R1), http //wwwjch.org. 

Another approach is needed for procedures for the determination of impurities in active substances and excipients or degradation products in finished pharmaceutical products. These procedures may include quantitative assays as well as limit tests. Impurities of interest are various, including metals such as lead and other inorganic substances, catalysts, genotoxic impurities, residual solvents etc. Details can be found in the scientific guidelines on e.g. quality from EMA [22], see also Sect. 22.4.2. 

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