ArticleFrontiers in toxicology2025
Reproduction of the human relevant potency threshold (HRPT) for estrogen receptor alpha agonism in an inference performance screen for ICCVAM's regulatory scientific confidence framework.
Article in Frontiers in toxicology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Scientific confidence frameworks (SCFs) are alternatives to traditional validation for new approach methodologies (NAMs). The SCFs adapted by the Interagency Coordinating Committee for the Validation of Alternative Methods (ICCVAM) and the American Chemistry Council (ACC) both address inference performance-the ability of NAMs to predict or inform the biological effect of interest. Inference performance is a distinct evaluation procedure in ACC's SCF but is blended into several steps of ICCVAM's SCF. Here, we first reproduce the previously derived human relevant potency threshold (HRPT) for the estrogen receptor alpha (ERα) agonism of Borgert et al. (2018) using guideline and guideline-like studies; we found that a HRPT of 1 to 10
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