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An analysis of the Washington Conference Report on bioanalytical method validation

C Hartmann1, D L Massart, R D McDowall

  • 1Pharmaceutical Institute, Vrije Universiteit Brussel, Belgium.

Journal of Pharmaceutical and Biomedical Analysis
|November 1, 1994
PubMed
Summary

Strict interpretation of bioanalytical method validation guidelines may cause issues. Separating bias and precision errors ensures methods meet the +/- 15% acceptance interval, requiring bias and precision below 8% relative standard deviation.

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Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Science
  • Biotechnology

Background:

  • Bioanalytical method validation is crucial for drug development and regulatory submissions.
  • Existing guidelines, like the Washington Conference Report, set standards for accuracy and precision.
  • Literal interpretation of these standards can lead to practical challenges in method implementation.

Purpose of the Study:

  • To analyze the Washington Conference Report's requirements for bioanalytical method validation.
  • To evaluate the practical implications of strict adherence to precision and accuracy criteria.
  • To propose an improved approach for assessing measurement error in bioanalytical methods.

Main Methods:

  • Analysis of the Washington Conference Report's recommendations on method validation.

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  • Decomposition of total measurement error into constant (bias) and random (precision) components.
  • Calculation of required bias and precision levels to meet acceptance intervals.

    • Main Results:

    • Literal interpretation of validation requirements can result in unmet expectations.
    • A strategy separating bias and precision provides a more practical assessment.
    • To achieve a 95% acceptance rate within +/- 15% of the true value, bias must be <= 8% and precision <= 8% relative standard deviation (RSD) with n=5.

    Conclusions:

    • A nuanced approach to bioanalytical method validation is necessary.
    • Separating bias and precision allows for more realistic and achievable validation targets.
    • The proposed error component analysis enhances the reliability of bioanalytical data in practice.