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|Title:||Method Validation and Reference Materials|
|Authors:||BELLOCCHI Gianni; BERTHEAU Yves; DE GIACOMO Marzia; HOLST-JENSEN Arne; MACARTHUR Roy; MAZZARA Marco; ONORI Roberta; TAVERNIERS Isabel; VAN DEN BULCKE Marc; TRAPMANN Stefanie|
|Publisher:||Blackwell Publishing Limited|
|Type:||Articles in periodicals and books|
|Abstract:||The producer of analytical results must ensure that these results are reliable and also that they have all the elements necessary for the user to feel confi dent in them. This is because analytical information can be used for a variety of purposes: to make decisions involving the control of the manufacturing process of a product, to assess whether a product complies with regulatory limits, and to make decisions about legal affairs, international trade, health problems or the environment. Procedures to improve the objectiveness of validation procedures must be introduced and adopted. Such limitations to current validation practices were recently outlined by the Molecular Biology and Genomics Unit (European Commission Joint Research Centre, Ispra, Italy), who advocate the use of fuzzy - logic based indicators for interpretation of validation results (Bellocchi et al., 2006, 2008, 2010a ). This approach has been implemented within the European research project Co - Extra for validating innovative methods such as array analysis and for providing a proof of concept for modular validation of analytical methods. In this chapter we will describe all of these validation techniques and associated issues, as well as an additional approach to combining validation statistics using uncertainty profi les.|
|JRC Directorate:||Institute for Health and Consumer Protection Historical Collection|
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