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Related Experiment Videos

Validation of analytical methods based on accuracy profiles.

Max Feinberg1

  • 1Institut National de la Recherche Agronomique (INRA), Met@risk, 16 rue Claude Bernard, 75231 Paris Cedex 05, France. feinberg@inapg.inra.fr

Journal of Chromatography. A
|March 9, 2007
PubMed
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This study introduces the accuracy profile, a graphical tool for analytical method validation. It simplifies deciding if a method is fit for purpose by comparing measurement intervals to user-defined acceptance criteria.

Area of Science:

  • Analytical Chemistry
  • Method Validation

Background:

  • Validation is crucial in analytical chemistry but suffers from conceptual ambiguity and complex terminology.
  • Existing validation approaches can be difficult for analytical chemists to interpret and apply.

Purpose of the Study:

  • To present a novel validation method based on the fitness-for-purpose approach.
  • To introduce the accuracy profile as a graphical decision-making tool for method validation.

Main Methods:

  • Developed a graphical decision-making tool, the accuracy profile.
  • Utilized measurements from reproducibility or intermediate precision conditions.
  • Calculated an interval predicting the location of future measurements.

Main Results:

Related Experiment Videos

  • The accuracy profile enables the computation of an interval for future measurements.
  • Comparison of the accuracy profile interval with an end-user defined acceptability interval facilitates validation decisions.

Conclusions:

  • The accuracy profile offers a clear and practical approach to method validation.
  • This method simplifies the experimental organization and conclusion-making process for analytical method validation.