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

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 d...

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Detalles Bibliográficos
Autor principal: Yim, Dong-Seok
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Korean Society for Clinical Pharmacology and Therapeutics 2018
Materias:
Review
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6989253/
https://www.ncbi.nlm.nih.gov/pubmed/32055567
http://dx.doi.org/10.12793/tcp.2018.26.4.145
Descripción
Sumario: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.

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