Global trends in drug development using alternatives to animal testing

Q: What does this research mean for the field?

New Approach Methodologies (NAMs), including human cell models and in silico analyses, offer improved predictive accuracy for human organ toxicity in drug development, though international regulatory harmonization remains necessary for their widespread adoption. Novelty: ClaimNovelty.SYNTHESIS. Consensus alignment: ConsensusAlignment.NEUTRAL.

Shota Yanagida; Hiroyuki Kawagishi; Yasunari Kanda

doi:10.1254/fpj.26042

August 31, 2026Folia Pharmacologica Japonica

Global trends in drug development using alternatives to animal testing

View at Publisher

Ask AI

Bookmark

Share

Key Points

Review global and domestic regulatory trends for New Approach Methodologies (NAMs) and evaluate progress in human cell-based assays for predicting drug-induced organ toxicity.
Reviewed international regulatory frameworks, Context of Use validation, and guideline harmonization efforts across global regulatory agencies.
Assessed preclinical platforms including human induced pluripotent stem cell-derived cardiomyocytes, neural multielectrode array systems, and three-dimensional hepatocyte cultures.
Human induced pluripotent stem cell-derived cardiomyocyte contractility assays successfully identified chronic contractile dysfunction associated with anticancer agents.
Multielectrode array platforms combining human induced pluripotent stem cell-derived or rat cortical neurons demonstrated improved sensitivity for detecting drug-induced seizure risks.
Three-dimensional cultures and human liver chimeric mouse-derived hepatocytes improved predictive accuracy for identifying drug-induced liver injury risks.

Ask about this paper

Answers are grounded in this paper and cite their sources.

Implication

Review highlights advances in human cell-based new approach methodologies for organ toxicity evaluation, indicating critical steps toward replacing traditional animal testing.

Abstract

No abstract yet. The journal hasn't published one we can show.

Discussion

No takes yet. Share an insight, caveat, or question.

Cite This Study

Yanagida et al. (2026) studied this question.

synapsesocial.com/papers/6a993503636c6408cfa7cc8f https://doi.org/10.1254/fpj.26042

View at Publisher

Ask AI

Bookmark

Share

Global trends in drug development using alternatives to animal testing

Key Points

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Global trends in drug development using alternatives to animal testing

Key Points

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Keep reading

Keep reading