ICH Explains How To Assess Mutagenic Impurities To Limit Carcinogenic Risk

New guidance that the International Council for Harmonisation says provides a practical framework for identifying, categorizing, qualifying and controlling mutagenic impurities to limit potential carcinogenic risk is now ready for implementation in the ICH regions.

drug development — A new guidance deals with assessing the mutagenic potential of impurities • Source: Shutterstock

Synthetic impurities, degradation products and considerations for clinical development are among a raft of topics discussed in a newly adopted guideline by the International Council for Harmonisation on the assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk.

The ICH has also adopted an addendum to accompany the guideline. The addendum describes acceptable intakes or permissible daily...