In 2020, ICH E14/S7B cardiac safety regulations was updated: The role of in vitro assays was expanded and the “Double-Negative” scenario was suggested. Therefore, we develop a systematic strategy to assess preclinical cardiac safety: CardiacOneTM
Our CardiacOneTM will assess cardiotoxicity in three aspects: electrophysiological abnormalities, contractile dysfunction, and structural toxicity
Cardiac pharmacological study platform
Multiple cardiac ion channel patch clamp or automated patch clamp (Beyond CiPA related channels)
Cardiac pharmacological study using acutely isolated cardiomyocytes (from human, monkey, canine, rabbit, Guinea pig, rats or mice) or iPSCs-derived cardiomyocytes
Langendorff perfusion of isolated heart and in vivo ECG recording
Cardiac action potential assays of Purkinje fibers and papillary muscle
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