Long-term electrocardiographic safety monitoring in clinical drug development: A report from the Cardiac Safety Research Consortium.
Am Heart J
; 187: 156-169, 2017 May.
Article
em En
| MEDLINE
| ID: mdl-28454799
ABSTRACT
This white paper, prepared by members of the Cardiac Safety Research Consortium (CSRC), discusses important issues regarding scientific and clinical aspects of long-term electrocardiographic safety monitoring during clinical drug development. To promote multistakeholder discussion of this topic, a Cardiac Safety Research Consortium-sponsored Think Tank was held on 2 December 2015 at the American College of Cardiology's Heart House in Washington, DC. The goal of the Think Tank was to explore how and under what circumstances new and evolving ambulatory monitoring technologies could be used to improve and streamline drug development. This paper provides a detailed summary of discussions at the Think Tank it does not represent regulatory guidance.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Monitoramento de Medicamentos
/
Avaliação de Medicamentos
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Eletrocardiografia
Tipo de estudo:
Guideline
Limite:
Humans
Idioma:
En
Revista:
Am Heart J
Ano de publicação:
2017
Tipo de documento:
Article