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.
Article
in Chinese
| 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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Technology
/
China
/
Data Collection
/
Equipment and Supplies
Limits:
Child
/
Humans
Country/Region as subject:
Asia
Language:
Chinese
Journal:
Chinese Journal of Medical Instrumentation
Year:
2019
Type:
Article
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