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Author

A. Trejo-Martin

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Open access Sep 2026

Applicability of the ICH M7 Guidelines for Assessing Less-than-Lifetime Exposure to Nitrosamine Impurities in Drug Products.

Global regulators identified several data gaps that precluded acceptance of the ICH M7 framework for assessing less-than-lifetime (LTL) exposures to N-nitrosamine (NA) impurities in drug products. Building on prior analyses confirming that NA carcinogenic potency is driven by lifetime cumulative dose, this work address...

S. Felter, J. Bercu, Robert A. Jolly et al. · 0 citations

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