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  • Title: [Analytical validation in compendium methods].
    Author: Kaniwa N, Matsuda R, Ishibashi M.
    Journal: Eisei Shikenjo Hokoku; 1993; (111):141-2. PubMed ID: 7920558.
    Abstract:
    Well validated analytical methods should be used in official tests in order to eliminate the type I and II errors. The analytical validation is the process to confirm that the performance characteristics of a proposed analytical method is adequate for its intended use. The performance characteristics of an analytical method are validated by evaluating that observed analytical performance parameters of the analytical method meet the criteria required by a test to which the analytical method is applied. Basic rules in analytical validation were described in this report. The more strict rules for determination of the limit of detection and the test of precision than usually applied were proposed.
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