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Biomarker Validation: Context and Complexities
Published online by Cambridge University Press: 01 January 2021
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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