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Biomarker Validation: Context and Complexities

Published online by Cambridge University Press:  01 January 2021

Lisa M. McShane
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Abstract

Validation of a biomarker-based medical product development tool or clinical test is an evidentiary process that must be tailored to the proposed use. Appropriate data and analyses are needed to demonstrate that the biomarker meets analytical and clinical performance criteria consistent with favorable benefit: risk balance.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 47 , Issue 3: Biomarker Research and Validation: Current Challenges, Future Opportunities , Fall 2019 , pp. 388 - 392
Copyright
Copyright © American Society of Law, Medicine and Ethics 2019

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