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The thorough QT/QTc study 4 years after the implementation of the ICH E14 guidance
The ICH E14 guidance on how to clinically assess a new drug's liability to prolong the QT interval was adopted in May 2005. A centre-piece of the guidance was the establishment of one single trial, the ‘thorough QT/QTcstudy’, intended to confidently identify drugs that may cause QT prolongation...
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Formato: | Artigo |
Idioma: | Inglês |
Publicado em: |
Blackwell Publishing Ltd
2010
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Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC2823351/ https://ncbi.nlm.nih.gov/pubmed/19922536 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/j.1476-5381.2009.00487.x |
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