Overview
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Morgan GERMA: Collaborator at Joseph Fourier University, Grenoble, Master CQAQMV
INTRODUCTION
Various guides deal with validation methods: SH GTA 04, norme NF X 90-210, guide SFSTP or SFBC. The common objective of these guides is to study methods for identifying factors leading to errors in results, and to help quantify and interpret them.
With the same objective in mind, here is a list of additional tests that should not be overlooked:
contamination or memory effect ;
reagent stability ;
method correlation ;
sensitivity ;
specificity.
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Other validation tests
Bibliography
Analytical validation guide: SFSTP commission report: 1994 and 2006
Guideline ICHQ2 (R1), Validation of Analytical Procedures: text and methodoly
NF T 90-210, Protocole d'évaluation initiale des performances d'une méthode dans un laboratoire – AFNOR – 2009
From validation of analytical methods to...
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