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Modernizing Federal Oversight of Laboratory-Developed Tests - Toward Safety, Validity, and Utility

Udit Singhal1, Caroline Horrow1, Aaron S Kesselheim1

  • 1From the Department of Urology, Rogel Cancer Center, University of Michigan, Ann Arbor (U.S., T.M.M.); the Department of Urology, Mayo Clinic, Rochester, MN (U.S.); and the Program on Regulation, Therapeutics, and Law, Brigham and Women's Hospital and Harvard Medical School, Boston (C.H., A.S.K.).

The New England Journal of Medicine
|November 6, 2023
PubMed
Abstract

No abstract available in PubMed .

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Data Validation01:15

Data Validation

Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
Key parameters for method validation include:
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