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    Harmonization of Methodology: International Perspective

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    Not long ago, most experimentation dealing with analytical methodology in the physical and biological sciences was conducted within a single laboratory. Method validation by other laboratories was not only considered unnecessary but also detrimental because, in the words of one commentator, “the results are too variable.” Within the last two decades, however, largely as a result of the requirements of international environmental and food standards programs, it has become increasingly apparent that a collaborative interlaboratory study is the only way to estimate the systematic and random error characteristics of methods of analysis as they will be performed by the population of laboratories typical of those who will be using the method. To obtain a common basis for measuring the statistical characteristics of analytical methods, representatives of almost two dozen international organizations meeting in Geneva in May 1987 approved by consensus a protocol that will be useful for the design and interpretation of collaborative studies of chemical methods of analysis. Much of this protocol will also be useful for the study of biological measurement methods.


    methods of analysis, accuracy, precision, interlaboratory studies, proficiency studies, collaborative studies, systematic error, random error, performance parameters

    Author Information:

    Horwitz, W
    Scientific advisor, Food and Drug Administration HFF-7, Washington, DC

    Committee/Subcommittee: E47.91

    DOI: 10.1520/STP16758S