Five years of the CiPA project (2013–2018): what did we learn?
Translational and Clinical Pharmacology
;
: 145-149, 2018.
Artigo
em Inglês
| WPRIM
| ID: wpr-742423
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.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Simulação por Computador
/
Morte Súbita Cardíaca
/
Miócitos Cardíacos
/
Recall e Retirada de Produto
/
Europa (Continente)
/
Canais Iônicos
/
Japão
País/Região como assunto:
Ásia
/
Europa
Idioma:
Inglês
Revista:
Translational and Clinical Pharmacology
Ano de publicação:
2018
Tipo de documento:
Artigo
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