ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk is now fully implemented and makes available a variety of approaches to control potentially genotoxic impurities (PGIs) based on the maximum daily dose, duration of use, and indication of the drug product. The limit to which a PGI is controlled, based on these factors is defined as the threshold of toxicological concern or TTC.
Once the need for control of a PGI is identified and the standardized deficiency from DLAPI is issued, a firm can use any of the following approaches as a control strategy in their response:
1) Use Options 1-4 provided in ICH M7
2) Provide negative (Q)SAR data
3) Provide a complete AMES study
2) Provide negative (Q)SAR data
3) Provide a complete AMES study
This poster provides a survey of the choices DMF holders have submitted to the Agency to control PGIs based on ICH M7.
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