Article (Scientific journals)
Harmonization of strategies for the validation of quantitative analytical procedures: a SFSTP proposal part IV. Examples of application.
Hubert, Philippe; Nguyen-Huu, J.-J.; Boulanger, Bruno et al.
2008In Journal of Pharmaceutical and Biomedical Analysis, 48 (3), p. 760-71
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Abstract :
[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.
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Hubert, Philippe  ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Nguyen-Huu, J.-J.
Boulanger, Bruno ;  Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Chapuzet, E.
Cohen, N.
Compagnon, P.-A.
Dewé, Walthère ;  Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments - Département de mathématique
Feinberg, M.
Laurentie, Michel
Mercier, N.
Muzard, G.
Valat, L.
Rozet, Eric ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
More authors (3 more) Less
Language :
English
Title :
Harmonization of strategies for the validation of quantitative analytical procedures: a SFSTP proposal part IV. Examples of application.
Publication date :
2008
Journal title :
Journal of Pharmaceutical and Biomedical Analysis
ISSN :
0731-7085
eISSN :
1873-264X
Publisher :
Elsevier Science, Oxford, United Kingdom
Volume :
48
Issue :
3
Pages :
760-71
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 13 February 2009

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