Diagnostic Device Evaluation

Authored by: Meijuan Li , Tinghui Yu , Qin Li , Gene Pennello , R. Lakshmi Vishnuvajjala , Bipasa Biswas , Changhong Song , Lilly Q. Yue

Encyclopedia of Biopharmaceutical Statistics

Print publication date:  August  2018
Online publication date:  August  2018

Print ISBN: 9781498733953
eBook ISBN: 9781351110273
Adobe ISBN:


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A diagnostic medical device is used alone or with other information to help assess a past, present, or future health condition of a subject. This entry provides general considerations for measurement validation and clinical validation of diagnostic devices from a statistical perspective. This entry also discusses issues with diagnostic device training and validation as well as decision analysis.

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