GMP: Genotoxic impurities: the new ICH M7 addendum to calculation of compound-specific acceptable intakes

The final document of the ICH-Guideline M7 was published in June 2014. It describes the procedure for evaluating the genotoxic potential of impurities in medicinal products (see also our news Final ICH M7 Guideline on Genotoxic Impurities published dated 23 July 2014).

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