devTOX quickPredictTM Accurately Predicts the Developmental Toxicity Potential of the ICH S5(R3) Guideline Reference Compounds [SOT 2022]

Presented by Jessica Palmer at the Society for Toxicology (March, 2022)

There have been increased efforts in the pharmaceutical and chemical industries to incorporate new approach methods (NAMs) (in vitro, ex vivo, or in silico) earlier in the product development pipeline prior to in vivo testing.

  • New guidelines have been released by regulatory agencies that permit the use of NAMs in conjunction with or in place of the traditional in vivo embryo-fetal development (EFD) studies.
  • In particular, the revised S5 (R3) guideline on Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals recently issued by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) defines specific scenarios where qualified NAMs can be used to defer or replace conventional in vivo testing or as part of a weight of evidence assessment.
  • The devTOX quickPredictTM (devTOXqP) assay is an in vitro human pluripotent stem (hPS) cell-based assay that predicts the developmental toxicity potential of chemicals based on changes in ornithine and cystine metabolism.
  • In this study, the devTOXqP assay was used to assess the developmental toxicity potential of the 29 ICH-positive reference compounds and 22 negative compounds. Assay accuracy was assessed by comparing the assay results to human, rodent, and rabbit plasma concentrations.

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