22 April 2021 | News
Aims to help pharmaceutical companies better develop and market drugs
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The Ministry of Food and Drug Safety (MFDS) in Korea has published a guidance on cardiovascular safety pharmacology evaluation method, which aims to help pharmaceutical companies better develop and market drugs.
Details of the guidance include introduction of cardiovascular safety pharmacology test; explanation of evaluation test method for multi-cardiac ion channels, and explanation of evaluation test method for cardiomyocyte cell action potential derived from Human Induced Pluripotent Stem Cells (hiPSCs).
Specifically, considering that the hERG channel assay, that is used in the existing safety pharmacology evaluation, has limitations in accurately predicting clinical arrhythmia, the multi-cardiac ion channel evaluation test method using sodium and calcium channels and the action potential evaluation method using cardiomyocytes derived from hiPSCs have been newly established.