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Author Spotlight: Biological Standardization to Ensure Reproducibility and Harmonization in Research
Published on: August 4, 2023
Stability: recommendation for best practices and harmonization from the Global Bioanalysis Consortium Harmonization
Nico van de Merbel1, Natasha Savoie, Manish Yadav
1Bioanalytical Laboratory, PRA, Westerbrink 3, 9405 BJ, Assen, The Netherlands, merbelnicovande@praintl.com.
Abstract:
This paper provides a comprehensive overview of stability-related aspects of quantitative bioanalysis and recommends science-based best practices, covering small and large molecules as well as chromatographic and ligand-binding assays. It addresses general aspects, such as the use of reference values, transferability and treatment of failing stability results, and also focuses on specific types of stability assessment: bench-top, freeze/thaw and long-term frozen stability, stock stability, extract stability, stability in whole blood, tissue and urine, and stability of endogenous analytes, in special matrix types and in incurred samples.
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