Five years of the CiPA project (2013–2018): what did we learn?
10.12793/tcp.2018.26.4.145
- Author:
Dong Seok YIM
1
Author Information
1. Department of Clinical Pharmacology and Therapeutics, Seoul St. Mary's Hospital, Seoul 06591, Korea. yimds@catholic.ac.kr
- Publication Type:Review
- Keywords:
Cardiomyocytes;
CiPA;
hERG;
In silico;
JT(peak)
- MeSH:
Computer Simulation;
Death, Sudden, Cardiac;
Europe;
Ion Channels;
Japan;
Myocytes, Cardiac;
Product Recalls and Withdrawals
- From:Translational and Clinical Pharmacology
2018;26(4):145-149
- CountryRepublic of Korea
- Language:English
-
Abstract:
Cases of drug-induced QT prolongation and sudden cardiac deaths resulted in market withdrawal of many drugs and world-wide regulatory changes through accepting the ICH guidelines E14 and S7B. However, because the guidelines were not comprehensive enough to cover the electrophysiological changes by drug-induced cardiac ion channel blocking, CiPA was initiated by experts in governments and academia in the USA, Europe, and Japan in 2013. Five years have passed since the launch of the CiPA initiative that aimed to improve the current ICH guidelines. This report reviews the current achievements of the CiPA initiative and explores unresolved issues.
