At present, owing to the species differences, we have little options for preclinical studies to predict adverse effects (AEs) in the human CNS.  However, as introduced in this symposium, a series of new in vitro experiments have been developed to improve the predictability of CNS AEs. This trend is not limited to Japan inside, but also seen worldwide. Our research project ‘iPSC Non-Clinical Experiments for Nervous System(iNCENS)', aiming at the establishment of the evaluation systems to predict seizure risks of new drugs, is now a committee member of an international think tank, International Life Sciences Institute (ILSI), Health and Environmental Sciences Institute (HESI), NeuTox micro-electrode array (MEA) sub team. Most megapharmas and regulatory agencies are participating in the pilot study to clarify the efficiency of the electrophysiological recordings of MEA. We are providing some promising data recorded from hiPSC-neurons. In this symposium, I will introduce our on-going activities together with the global trends concerning the development of preclinical in vitro evaluation systems to predict CNS AEs.

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