Reference : Harmonization of strategies for the validation of quantitative analytical procedures: a ...
Scientific journals : Article
Human health sciences : Pharmacy, pharmacology & toxicology
http://hdl.handle.net/2268/6171
Harmonization of strategies for the validation of quantitative analytical procedures: a SFSTP proposal part IV. Examples of application.
English
Hubert, Philippe mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Nguyen-Huu, J.-J. [> > > >]
Boulanger, Bruno [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
Chapuzet, E. [> > > >]
Cohen, N. [> > > >]
Compagnon, P.-A. [> > > >]
Dewé, Walthère [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments - Département de mathématique >]
Feinberg, M. [> > > >]
Laurentie, Michel [> > > >]
Mercier, N. [> > > >]
Muzard, G. [> > > >]
Valat, L. [> > > >]
Rozet, Eric mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
2008
Journal of Pharmaceutical & Biomedical Analysis
Elsevier Science
48
3
760-71
Yes (verified by ORBi)
International
0731-7085
Oxford
United Kingdom
[en] A harmonized approach for the validation of analytical methods based on accuracy profile was introduced by a SFSTP commission on the validation of analytical procedure. This fourth and last document aims at illustrating this methodology and the statistics used. Therefore the validation of real case methods are proposed such as methods for the quality control of drugs, for the quantitation of impurities in drug substances, for bioanalysis or for the determination of nutriments. Furthermore, different types of analytical methods are used in order to demonstrate the applicability of the proposed approach to a wide range of methods such as liquid chromatography (LC-UV, LC-MS), spectrophotometry or ELISA.
Researchers ; Professionals ; Students
http://hdl.handle.net/2268/6171
10.1016/j.jpba.2008.07.018

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