A proposed addendum to the ICH M7 guideline discusses the derivation of acceptable intakes for mutagenic impurities with positive carcinogenicity data. In this addendum, such values have been derived for a set of common mutagens and carcinogens.

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (2015). Addendum to ICH M7: assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk. Application of the principles of the ICH M7 guideline to calculation of compound-specific acceptable intakes. Guideline M7(R1). Current Step 2 version dated 9 June 2015. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M7/M7_Addendum_Step_2.pdf

 

The above items were taken from the September 2015 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here)

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