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.