Evaluation of the reference chemicals suggested in the draft ICH S5(R3) guideline with a human pluripotent stem cell-based developmental toxicity assay [SOT 2019]

Presented at the Society of Toxicology Annual Meeting and ToxExpo in Baltimore, Maryland; March 2019.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) recently released the draft S5(R3) Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals. The revised guideline would allow the use of in vitro, ex-vivo, and non-mammalian in vivo embryo-fetal development alternative assays to replace or eliminate in vivo studies in certain circumstances and provides a framework for qualifying alternative test systems for regulatory acceptance.

The draft guidance includes a list of reference chemicals aimed at defining the applicability domain of an alternative assay. Stemina has evaluated many of the compounds in this list with the devTOX quickPredict (devTOXqP) assay, which is an in vitro human pluripotent stem (hPS) cell-based assay that predicts the developmental toxicity potential of chemicals based on changes in hPS cell metabolism. The results from this evaluation, as well as how devTOXqP can be used with other NAMs in an integrated testing strategy will be discussed.

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