Importance of Genotoxicity & S2A guidelines for genotoxicity testing for pharmaceuticals:

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Ich Harmonised Tripartite Guideline Genotoxicity : a Standard Battery for Genotoxicity Testing of Pharmaceuticals

ICH guideline S2 (R1) - Genotoxicity testing and data interpretation for pharmaceuticals intended for human use

A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity.

The synthesis of pharmaceutical products frequently involves the use of reactive reagents and the formation of intermediates and by-products. Low levels of some of these may be present in the final drug substance and drug product as impurities. Such chemically reactive impurities may have at the same time the potential for unwanted toxicities including genotoxicity and carcinogenicity and hence...

Genotoxicity Testing: a Review

Genotoxicity is a major limitation of various compounds used in clinical practices which range from gene mutations, chromosomal aberrations to other DNA effects. For the same reason, it must be assessed before bringing into the market. Moreover, various regulatory agencies have made it mandatory to submit the genotoxicity data while filing a New Drug Application (NDA). This in turn has given fu...

High-Throughput Genotoxicity Testing

The registration of all pharmaceuticals requires a comprehensive safety assessment of their potential to cause direct or indirect genotoxic damage. This article reviews current methods employed for regulatory genotoxicity testing and new techniques developed for early high-throughput screening. A novel in vitro mammalian assay is described which detects all common mechanistic classes of genotox...