Author

Timothy J. McGovern

2 papers indexed here

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Sep 2026

Beyond NAMs versus animal models: Context of use as the governing framework for integrated nonclinical strategies in drug development.

New approach methodologies (NAMs) originated in chemical hazard assessment, where two forces operate together: the scale of characterizing many substances, and a long-standing ethical and legal commitment to replacing animal testing. Drug development is weighted differently. It is a translational and decision problem a...

Stefano Gaburro, B. Berridge, Nicholas W. Kelley et al. · Regulatory toxicology and ph... · 0 citations

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