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Risk-based approach for the transfer of quantitative methods: bioanalytical applications
1Laboratory of Analytical Chemistry, Bioanalytical Chemistry Research Unit, University of Liège, B-4000 Liège 1, Belgium. Eric.Rozet@ulg.ac.be
Journal of Chromatography. A
|December 11, 2007
Summary
This study introduces advanced statistical methods for analytical method transfer, ensuring accuracy in receiving labs. These total error-based approaches improve reliability over traditional techniques for bioanalytical method validation.
Area of Science:
- Analytical Chemistry
- Bioanalytical Science
Background:
- Method transfer is crucial for routine bioanalysis.
- Conventional statistical methods for method transfer have limitations in guaranteeing accuracy.
Purpose of the Study:
- To demonstrate the applicability of new total error-based statistical approaches for bioanalytical method transfer.
- To evaluate the sufficiency of classical statistical methods in method transfer studies.
Main Methods:
- Application of two recent statistical approaches using total error-based criteria.
- Consideration of the uncertainty in the true value estimate from the sending laboratory.
- Successful application to two automated liquid chromatography-on-line solid-phase extraction methods for catecholamines in urine and N-methyl-laudanosine in plasma.
Main Results:
- The new statistical approaches were successfully applied to complex bioanalytical method transfers.
- Demonstrated the limitations of conventional methods in ensuring consistent accuracy.
Conclusions:
- Total error-based statistical approaches offer a more robust guarantee for bioanalytical method transfer.
- Recommendations are proposed for improving method transfer studies based on risk assessment.
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