[Cardiovascular safety pharmacology: in vitro strategies and improvements in technology and evaluation]

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.