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시스템 약리학 기술을 이용한 통합 생체 심혈관 안전성 예측 모델 구축 연구
오건희 ( Kunhee Oh ),김기석 ( Ki-suk Kim ),이향애 ( Hyang-ae Lee ),한승훈 ( Seunghoon Han ),임동석 ( Dong-seok Yim ) 한국동물실험대체법학회 2018 동물실험대체법학회지 Vol.12 No.1
ICH S7B and E14 guidelines, which were first released in 2005, are focused on hERG blockade and QT prolongation by drugs. However, cumulated evidences on some pitfalls of the guidelines resulted in the initiation of the comprehensive in vitro proarrhythmia assay (CiPA) project. Results of the CiPA are expected to change global regulatory environment on the cardiac safety of drugs. In this study, we reproduced two components of the CiPA to assess the performance of their in silico biomarker using in vitro ion channel assay data. The process to obtain qNET, a biomarker proposed by CiPA, was fully reproduced through in vitro and in silico studies in selected three drugs (verapamil, ranolazine, moxifloxacin). Throughout the reproducing research, we obtained many practical experiences not included in publications by the CiPA. For further understanding of this new regulatory paradigm, clinical ECG in human and another in silico method are to be performed.