Genotoxicity testing data interpretation

Mendelsohn ML, Moore DH, Lohman PHM. 1992. A method for comparing and combining short-term genotoxicity test data Results and interpretation. Mutat Res 266 43-60. 

US Federal Register (2008) International Conference on Harmonisation draft guidance on S2(R1) genotoxicity testing and data interpretation for pharmaceuticals intended for human use, availability, 73, p. 59. 

As discussed above, luminescent bacteria have been used successfully to measure acute toxicity of chemicals and oivironmental samples. In addition to acute toxicity testing, chemicals and environmental samples are often tested for potential genotoxicity. There are several validated methods in routine use for assessing genotoxicity of chemicals but they have been practical limitations. These limitations include high cost per test sample and complex protocols which necessitate highly trained personnel to obtain reproducible test data, and to provide reliable interpretation. 

FDA (2012) Guidance for Industry S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use. http //www.fda.gov/downloads/Drugs/Guidances/ ucm074931.pdf (accessed on October 14, 2015). 

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