Ed,
Assuming you are referring to ICH M7 Guideline, I provide my comments.
26 years ago, I worked on projects with carcinogens to elucidate the mechanisms of how the two carcinogens induce conformational changes in DNAs. It was hypothesized back then due to nicks in DNAs caused by the carcinogens.
Anyhow, when DNAs become reactive and mutagenic, they are highly carcinogenic and genotoxic.
Thus, reactive and mutagenic DNA impurities need to be controlled.
It is good that the M7 Guidelines are getting finalized.
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Original Message:
Sent: 04-08-2013 15:52
From: Edward Narke
Subject: M7 Draft Guidance
Anyone have any thoughts?
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Edward Narke
Regulatory Managing Director
DS InPharmatics
Phoenixville PA
United States
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