Validation; ICH; Total Error Approach; Accuracy Profile; Robustness; SFC
Résumé :
[en] Method validation is the process of proving that an analytical method is acceptable for its intended purpose. The present chapter defines the validation criteria described in regulatory documents. Despite the abundance of guidelines, the conclusion about method validity remains confused. In this context, the state-of-the-art validation methodology named total error approach is briefly explained as the methodology that should be followed for all method validations. Finally, a review of literature presents quantitative development and validation of supercritical fluid chromatography (SFC) methods considering a wide range of applications and analytical fields.
Centre/Unité de recherche :
CIRM - Centre Interdisciplinaire de Recherche sur le Médicament - ULiège
Disciplines :
Pharmacie, pharmacologie & toxicologie Chimie
Auteur, co-auteur :
Dispas, Amandine ; Université de Liège > Département de pharmacie > Chimie analytique
Lebrun, Pierre ; Université de Liège > Département de pharmacie > Chimie analytique
Hubert, Philippe ; Université de Liège > Département de pharmacie > Chimie analytique
Langue du document :
Anglais
Titre :
Chapter 11 - Validation of Supercritical Fluid Chromatography Methods
Date de publication/diffusion :
2017
Titre de l'ouvrage principal :
Supercritical Fluid Chromatography - Handbook in Separation Science
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