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Author

J. Bercu

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2 papers indexed here

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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
Review Aug 2026

Commentary - In silico acute oral toxicity models are fit for inclusion in GHS and DG Model Regulations Classification Criteria.

This commentary advocates for the inclusion of in silico acute oral toxicity (AOT) models within the classification criteria of the Globally Harmonized System (GHS) and Dangerous Goods (DG) Model Regulations. AOT data, traditionally derived from animal studies, are central to hazard classification and regulatory compli...

Matthew Schmitz, J. Bercu, Jessica C. Graham et al. · 0 citations

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