%0 Journal Article %1 Hubert.2004 %A Hubert, P. %A Nguyen-Huu, J. J. %A Boulanger, B. %A Chapuzet, E. %A Chiap, P. %A Cohen, N. %A Compagnon, P. A. %A Dewe, W. %A Feinberg, M. %A Lallier, M. %A Laurentie, M. %A Mercier, N. %A Muzard, G. %A Nivet, C. %A Valat, L. %D 2004 %J J.Pharm.Biomed.Anal. %K Analytical Chemistry Clinical France Laboratory Medical Pharmaceutical Reproducibility Results Societies Techniques diagnosis methods of standards %N 3 %P 579-586 %T Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal--Part I %U PM:15522533 %V 36 %X This paper is the first part of a summary report of a new commission of the Societe Francaise des Sciences et Techniques Pharmaceutiques (SFSTP). The main objective of this commission was the harmonization of approaches for the validation of quantitative analytical procedures. Indeed, the principle of the validation of theses procedures is today widely spread in all the domains of activities where measurements are made. Nevertheless, this simple question of acceptability or not of an analytical procedure for a given application, remains incompletely determined in several cases despite the various regulations relating to the good practices (GLP, GMP, ...) and other documents of normative character (ISO, ICH, FDA, ...). There are many official documents describing the criteria of validation to be tested, but they do not propose any experimental protocol and limit themselves most often to the general concepts. For those reasons, two previous SFSTP commissions elaborated validation guides

@article{Hubert.2004, abstract = {This paper is the first part of a summary report of a new commission of the Societe Francaise des Sciences et Techniques Pharmaceutiques (SFSTP). The main objective of this commission was the harmonization of approaches for the validation of quantitative analytical procedures. Indeed, the principle of the validation of theses procedures is today widely spread in all the domains of activities where measurements are made. Nevertheless, this simple question of acceptability or not of an analytical procedure for a given application, remains incompletely determined in several cases despite the various regulations relating to the good practices (GLP, GMP, ...) and other documents of normative character (ISO, ICH, FDA, ...). There are many official documents describing the criteria of validation to be tested, but they do not propose any experimental protocol and limit themselves most often to the general concepts. For those reasons, two previous SFSTP commissions elaborated validation guides }, added-at = {2010-02-05T11:28:39.000+0100}, author = {Hubert, P. and Nguyen-Huu, J. J. and Boulanger, B. and Chapuzet, E. and Chiap, P. and Cohen, N. and Compagnon, P. A. and Dewe, W. and Feinberg, M. and Lallier, M. and Laurentie, M. and Mercier, N. and Muzard, G. and Nivet, C. and Valat, L.}, biburl = {https://www.bibsonomy.org/bibtex/251957c418a6a7e71d74beb4362bce9e7/kanefendt}, interhash = {a81c21154f2590b6d892e78b3bd6f4a6}, intrahash = {51957c418a6a7e71d74beb4362bce9e7}, journal = {J.Pharm.Biomed.Anal.}, keywords = {Analytical Chemistry Clinical France Laboratory Medical Pharmaceutical Reproducibility Results Societies Techniques diagnosis methods of standards}, number = 3, pages = {579-586}, timestamp = {2010-02-05T11:28:42.000+0100}, title = {Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal--Part I}, url = {PM:15522533}, volume = 36, year = 2004 }