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A European Bioanalysis Forum recommendation for requiring a context-of-use statement for successful development and

Kyra J Cowan1, Ulrich Kunz2, Peter Blattmann3

  • 1Merck KGaA, Research & Development, Drug Metabolism & Pharmacokinetics New Biological Entities, 64293Darmstadt, Germany.

Bioanalysis
|August 5, 2024
PubMed
Abstract

Keywords:
Biomarker assay validationbiomarkerscontext-of-use statementregulatory guidance

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