Five years of the CiPA project (2013-2018): what did we learn?

Dong-Seok Yim

doi:10.12793/tcp.2018.26.4.145

Five years of the CiPA project (2013-2018): what did we learn?

Transl Clin Pharmacol. 2018 Dec;26(4):145-149. doi: 10.12793/tcp.2018.26.4.145. Epub 2018 Dec 19.

Author

Dong-Seok Yim^{1

2}

Affiliations

¹ Department of Clinical Pharmacology and Therapeutics, Seoul St. Mary's Hospital, Seoul 06591, Korea.
² PIPET (Pharmacometrics Institute for Practical Education and Training), College of Medicine, The Catholic University of Korea, Seoul 06591, Korea.

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.

Keywords: Cardiomyocytes; CiPA; In silico; JTpeak; hERG.

Publication types

Review