Why the study?
Active global efforts are underway to bridge the gap between non-clinical and clinical cardiovascular safety evaluation, particularly regarding drug-induced arrhythmia and anticancer drug-induced heart failure.
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Design
Review
In vitro CiPA models may improve proarrhythmia prediction; leaves open clinical translation pending prospective validation.
Safety pharmacology studies have been clearly defined through discussions at the International Council for Harmonization of Pharmaceutical Regulations (ICH), and are conducted as non-clinical studies according to the ICH S7A and S7B to ensure the safety of subjects participating in clinical studies. The representative of in vitro studies of cardiovascular system is hERG assay, but CiPA recommendations by FDA/HESI (multi-ion channel assays, simulation with in silico model using the multi-ion channel data, human iPS cell-derived cardiomyocyte assay), a new clinical risk prediction strategy that makes effective use of non-clinical data is being established. In addition, regarding the risk of heart failure that induced by anticancer drugs, which are attracting attention as a social problem, technology development has been made centering on human iPS cell-derived cardiomyocytes. There are many issues to be solved, but active challenges are being taken globally to bridge the gap between clinical and non-clinical.
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Takashi Yoshinaga (2021) studied this question.
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