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Updated: May 2, 2026

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.
This paper offers best practices for quantitative bioanalysis stability testing. It covers small and large molecules, various assays, and specific stability assessments for reliable results.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
- Biotechnology
Background:
- Quantitative bioanalysis is crucial for drug development and clinical diagnostics.
- Ensuring the stability of biological samples and analytes is essential for assay accuracy.
- Existing guidelines may not comprehensively cover all stability-related aspects.
Purpose of the Study:
- To provide a comprehensive overview of stability-related aspects in quantitative bioanalysis.
- To recommend science-based best practices for stability assessment.
- To address both general and specific stability testing scenarios.
Main Methods:
- Review and synthesis of current knowledge on bioanalytical stability.
- Discussion of general stability considerations (reference values, transferability, failing results).
- Detailed examination of specific stability assessments (bench-top, freeze/thaw, long-term frozen, stock, extract, whole blood, tissue, urine, endogenous analytes, incurred samples).
Main Results:
- Established best practices for various stability studies.
- Recommendations for handling specific matrix types and endogenous analytes.
- Guidance on stability assessment in incurred samples.
Conclusions:
- Implementing standardized, science-based stability testing is vital for reliable quantitative bioanalysis.
- Comprehensive stability assessment protocols enhance data integrity.
- Adherence to best practices ensures the quality and reproducibility of bioanalytical results across different assays and matrices.
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