What does this research mean for the field?

While New Approach Methodologies (NAMs) offer significant opportunities to improve nonclinical safety assessment, current scientific and technical limitations dictate they must be used as complementary tools rather than full replacements for animal studies. Novelty: ClaimNovelty.SYNTHESIS. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

To provide an expert toxicologic pathology perspective on the opportunities, technical limitations, and regulatory roadmaps surrounding the integration of New Approach Methodologies (NAMs) in drug and chemical safety testing.

August 30, 2026Toxicologic PathologyOpen Access

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

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To provide an expert toxicologic pathology perspective on the opportunities, technical limitations, and regulatory roadmaps surrounding the integration of New Approach Methodologies (NAMs) in drug and chemical safety testing.
Joint working group assessment by the European Society of Toxicologic Pathology and the US Society of Toxicologic Pathology.
Expert evaluation of regulatory strategies, such as the US FDA April 2025 roadmap and European initiatives aiming to phase out animal testing.
Qualitative analysis of in vitro, in silico, and refined in vivo models within nonclinical safety evaluation frameworks.
NAMs enhance human biological relevance, testing efficiency, and animal welfare standards in early safety screening.
Current technical and biological constraints prevent NAMs from fully replacing comprehensive in vivo animal models across all testing contexts.
Successful implementation requires validating NAMs for defined contexts of use and leveraging toxicologic pathologists to bridge traditional and emerging assessment methods.

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Implication

Expert opinion reviews new approach methodologies in nonclinical drug development, indicating they act as complementary tools rather than complete replacements for animal safety studies.

Cite This Study

Stokar‐Regenscheit et al. (2026) studied this question.

synapsesocial.com/papers/6a93f0a36c1a8fb52e79ce58 https://doi.org/10.1177/01926233261455350

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Implication

Expert opinion reviews new approach methodologies in nonclinical drug development, indicating they act as complementary tools rather than complete replacements for animal safety studies.

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

Key Points

Discussion

Implication

Cite This Study

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

Key Points

Discussion

Implication

Cite This Study

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