Regulatory Aspects in Assessment and Control of DNA Reactive (Mutagenic) Impurities in API’s and Final Products to Limit Potential Cancer Risk as Per ICH M7
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Abstract
The ICH M7 guidelines for DNA reactive (mutagenic) impurities elaborate on the assessment and control of genetically damage-causing impurities in API and finished products. This suggested adopting the in-sillico (Q) SAR models and bacterial mutagenicity assays by industries and regulatory agencies for evaluation, as well as the acceptance of various control strategies to lower the risk of carcinogenic properties of substances. This paper discusses principles for evaluating and assessing such impurities that will support the path of regulatory submissions.
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References
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