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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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
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author Yim, Dong-Seok
author_facet Yim, Dong-Seok
author_sort Yim, Dong-Seok
collection PubMed
description 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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spelling pubmed-69892532020-02-13 Five years of the CiPA project (2013–2018): what did we learn? Yim, Dong-Seok Transl Clin Pharmacol Review 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. Korean Society for Clinical Pharmacology and Therapeutics 2018-12 2018-12-19 /pmc/articles/PMC6989253/ /pubmed/32055567 http://dx.doi.org/10.12793/tcp.2018.26.4.145 Text en Copyright © 2018 Translational and Clinical Pharmacology http://creativecommons.org/licenses/by-nc/3.0/ It is identical to the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/).
spellingShingle Review
Yim, Dong-Seok
Five years of the CiPA project (2013–2018): what did we learn?
title Five years of the CiPA project (2013–2018): what did we learn?
title_full Five years of the CiPA project (2013–2018): what did we learn?
title_fullStr Five years of the CiPA project (2013–2018): what did we learn?
title_full_unstemmed Five years of the CiPA project (2013–2018): what did we learn?
title_short Five years of the CiPA project (2013–2018): what did we learn?
title_sort five years of the cipa project (2013–2018): what did we learn?
topic Review
url 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
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