Article | REF: P225 V2

From validated method to validated results

Authors: Max FEINBERG, Serge RUDAZ

Publication date: September 10, 2019, Review date: May 23, 2023

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3. Validation principles and critical points

From the literature, it is possible to identify what might be termed "classic" validation procedures. In this respect, the UIPAC directive can be considered a typical example . The common elements of these relatively numerous documents are as follows:

  • a short or long list of characteristics to be covered by the validation study;

  • one or more parameters for each feature, to provide a quantitative or qualitative estimate (figure-of-merit ).

If no criteria are explicitly indicated in the document, the laboratory...

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Validation principles and critical points