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Blood stability testing: European Bioanalysis Forum view on current challenges for regulated bioanalysis
Achim Freisleben1, Margarete Brudny-Klöppel, Hans Mulder
1Merck Serono, Am Feld 32, D 85567 Grafing. achim.freisleben@merck.de
The European Bioanalysis Forum (EBF) recommends standardized blood stability testing protocols for method development and validation. This aims to harmonize processes, timing, and reporting for reliable bioanalytical assay results.
Area of Science:
- Bioanalytical chemistry
- Pharmacokinetics
- Drug development
Background:
- Blood stability testing is crucial for accurate bioanalytical method development and validation.
- The European Bioanalysis Forum (EBF) has focused on harmonizing these processes since 2008.
Purpose of the Study:
- To summarize EBF's conclusions on blood stability testing.
- To provide recommendations for experimental conduct and inclusion in method validation.
- To foster a globally harmonized approach to blood analyte stability.
Main Methods:
- Review and synthesis of EBF discussions and conclusions.
- Proposal of a step-wise approach for blood stability testing.
- Recommendation to use qualified assays for analyzing blood fractions.
Main Results:
- Established conclusions from EBF discussions on blood stability testing.
- Proposed recommendations for conducting stability assays.
- Highlighted the importance of using qualified assays to overcome experimental challenges.
Conclusions:
- Standardized blood stability testing is essential for reliable bioanalysis.
- The recommendations aim to align processes, timing, and reporting.
- Further scientific input is invited to refine global harmonization efforts.
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