The Exploration of Extrapolation of Data from Adults to Pediatric Population / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 375-378, 2019.
Artigo
em Chinês
| WPRIM
| ID: wpr-772480
ABSTRACT
Pediatric medical devices cannot meet the existing medical needs now. In consideration of the difficulty that clinical trials conducted in pediatric population, reasonable extrapolation of adult device data to pediatric population can maximize the use of existing data, as well as reduce unnecessary clinical trials in pediatric populations. It can also help accelerate the development and marketing of pediatric medical devices and ensure the clinical demand of pediatric devices. We analyzed the related guiding principles in America, and explored the extrapolation of medical device data to pediatric population in China from the perspective of medical device technology evaluation, hoping to provide reference in promoting China's data extrapolation.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Tecnologia
/
China
/
Coleta de Dados
/
Equipamentos e Provisões
Limite:
Criança
/
Humanos
País/Região como assunto:
Ásia
Idioma:
Chinês
Revista:
Chinese Journal of Medical Instrumentation
Ano de publicação:
2019
Tipo de documento:
Artigo
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