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Biomarkers for pharmacogenetic and pharmacogenomic studies: Locking down analytical performance
Elizabeth Mansfield1, Zivana Tezak1, Sousan Altaie1
1Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20850, USA.
Proper assessment of in vitro biomarker tests is crucial for drug development and personalized medicine. Analytical validation ensures reliable results for pharmacogenetic and pharmacogenomic studies.
Area of Science:
- Biomarker discovery and validation
- Pharmacogenetics and pharmacogenomics
- In vitro diagnostics
Background:
- In vitro biomarker tests are essential for developing new drugs and enabling personalized medicine.
- Accurate assessment of these tests is critical for meaningful results in drug development and companion diagnostics.
- The analytical performance of biomarker tests must be thoroughly characterized.
Purpose of the Study:
- To outline key analytical validation considerations for in vitro diagnostic test systems.
- To emphasize the importance of rigorous assessment for biomarker tests used in pharmacogenetic and pharmacogenomic studies.
Main Methods:
- This article provides a review of analytical validation principles.
- It focuses on issues relevant to the development and assessment of in vitro diagnostic tests.
Main Results:
- Key analytical validation issues are presented.
- Guidance is offered for ensuring test performance in pharmacogenetic and pharmacogenomic applications.
Conclusions:
- Thorough analytical validation is indispensable for reliable biomarker testing.
- Well-characterized in vitro diagnostic tests are fundamental for advancing drug development and personalized medicine.
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