ICH: M7 Guidline reaches Step 4

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ICH: M7 Guidline reaches Step 4
The ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk has reached Step 4 of the ICH process and is now entering the implementation period (Step 5). The final draft isbeing recommended for adoption to the regulatory bodies of the European Union, Japan and the USA.
The focus of this guideline is on DNA reactive substances that have a potential to directly cause DNA damage when present at low levels leading to mutations and therefore, potentially causing cancer. It offers guidance on analysis of structure activity relationships (SAR) for genotoxicity. Furthermore, it is intended to resolve questions such as whether impurities with similar alerts that potentially have similar mechanism of action should not be combined in calculating a Threshold of Toxicological Concern (TTC) and whether the TTC may differ based on differences in the approved duration of use.
The document is applicable for new drug substances and new drug products during their clinical development and subsequent applications for marketing. It is not intended for:
biological/biotechnological drug substances or products
peptides
oligonucleotides
radiopharmaceuticals
fermentation products
herbal products
crude products of animal or plant origin.
Because of the complexity of the 30-pages guideline, application of M7 is not expected prior to 18 months after ICH publication. However, there are some exceptions, e.g. ames test should be conducted according to M7 upon the ICH publication.
Source:
ICH: Newsroom

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andyouandme 发表于 2014-7-25 11:46
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清歌一曲月如霜

andyouandme 发表于 2014-7-25 11:46
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