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Selected Reaction Monitoring Mass Spectrometry for Absolute Protein Quantification
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Risk-based approach for the transfer of quantitative methods: bioanalytical applications.

E Rozet1, W Dewé, R Morello

  • 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
PubMed
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.

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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.