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B. Berridge

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Open access Aug 2026

Toxicologic Pathology Forum: ESTP/STP Working Group Opinion on the Evolving Landscape of New Approach Methodologies in Drug and Chemical Safety Development.

In April 2025, the US Food and Drug Administration (FDA) introduced a bold roadmap to phase out animal testing in drug development by promoting the integration of New Approach Methodologies (NAMs), beginning with monoclonal antibodies (mAbs). Similar roadmaps have also been created by European health authorities and ch...

N. Stokar-Regenscheit, B. Berridge, J. Kühnlenz et al. · 0 citations
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. · 0 citations

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