Article (Scientific journals)
An analysis of the SFSTP guide on validation of chromatographic bioanalytical methods: progresses and limitations
Boulanger, Bruno; Chiap, Patrice; Dewé, Walthère et al.
2003In Journal of Pharmaceutical and Biomedical Analysis, 32 (4-5), p. 753-765
Peer Reviewed verified by ORBi
 

Files


Full Text
articleBBoulangerSFSTP_2003.pdf
Publisher postprint (491.26 kB)
Request a copy

All documents in ORBi are protected by a user license.

Send to



Details



Keywords :
bioanalysis; method validation; statistics
Abstract :
[en] The Societe Francaise des Sciences et Techniques Pharmaceutiques (SFSTP) published in 1997 a guide on the validation of chromatographic bio-analytical methods, which introduces new concepts in three different areas: stages of the validation, test of acceptability of a method and design of experiments to perform. In 'stages of validation', the SFSTP guide requires two phases to validate a method. The first phase, called 'prevalidation', is intended to (1) identify the model to use for the calibration curve; (2) evaluate the limits of quantitation; and (3) provide good estimates of the precision and bias of the method before designing the 'validation' phase per se. In the 'test of acceptability', the use of the interval hypotheses is envisaged by the SFSTP guide, not on the parameters of bias and precision, but on individual results by mixing mean bias and intermediate precision in a single test. The SFSTP guide also avoids the use of Satterthwaite's df for testing the acceptability. The reasons for those choices are discussed extensively. In 'design of experiments', much effort has been devoted to improving the quality of results by optimally designing and sizing the experiments to perform in validation. The rationale for using near D-optimal designs for the calibration curve is demonstrated and sample sizes are proposed to correctly size the validation experiments. (C) 2003 Elsevier Science B.V. All rights reserved.
Disciplines :
Pharmacy, pharmacology & toxicology
Chemistry
Author, co-author :
Boulanger, Bruno ;  Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Chiap, Patrice  ;  Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Dewé, Walthère ;  Université de Liège - ULiège > Analyse des médicaments
Crommen, Jacques ;  Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Hubert, Philippe  ;  Université de Liège - ULiège > Chimie analytique
Language :
English
Title :
An analysis of the SFSTP guide on validation of chromatographic bioanalytical methods: progresses and limitations
Publication date :
08 August 2003
Journal title :
Journal of Pharmaceutical and Biomedical Analysis
ISSN :
0731-7085
eISSN :
1873-264X
Publisher :
Pergamon-Elsevier Science Ltd, Oxford, United Kingdom
Volume :
32
Issue :
4-5
Pages :
753-765
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 15 January 2010

Statistics


Number of views
150 (8 by ULiège)
Number of downloads
14 (0 by ULiège)

Scopus citations®
 
151
Scopus citations®
without self-citations
120
OpenCitations
 
106
OpenAlex citations
 
161

publications
153
supporting
2
mentioning
98
contrasting
0
Smart Citations
153
2
98
0
Citing PublicationsSupportingMentioningContrasting
View Citations

See how this article has been cited at scite.ai

scite shows how a scientific paper has been cited by providing the context of the citation, a classification describing whether it supports, mentions, or contrasts the cited claim, and a label indicating in which section the citation was made.

Bibliography


Similar publications



Sorry the service is unavailable at the moment. Please try again later.
Contact ORBi