Author

Robert A. Jolly

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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. · Regulatory toxicology and ph... · 0 citations

Open access Aug 2026

Differential Mutagenic Response of Rat Liver and Lung to Nicotine-Derived Nitrosamine Ketone (NNK)

Nitrosamines (NA) are chemical impurities that are present in tobacco, foods, more recently in some pharmaceuticals and are associated with genotoxicity and carcinogenicity. We evaluated the in vivo mutagenicity of nicotine-derived nitrosamine ketone (NNK) or 4-(methyl nitrosamino)-1-(3-pyridyl)-1-butanone, a model com...

Robert A. Jolly, J. Noteboom, D. LeBlanc et al. · Chemical Research in Toxicol... · 0 citations