%0 Journal Article %1 Hubert.2007b %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. %A Rozet, E. %D 2007 %J J.Pharm.Biomed.Anal. %K Analytical Calibration Chemistry Clinical France Laboratories Laboratory Medical Pharmaceutical Reference Reproducibility Research Results Societies Standards Techniques methods of standards %N 1 %P 70-81 %T Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal--part II %U PM:17646076 %V 45 %X As reported in a previous paper, the main objective of the new commission of the Societe Francaise des Sciences et Techniques Pharmaceutiques (SFSTP) was the harmonisation of approaches for the validation of quantitative analytical procedures. In a series of meetings, members of this Commission have first tried to review the objectives of analytical methods and the objectives of validation methods and to recommend the use of two-sided beta-expectation tolerance intervals for total error of validation samples (accuracy profile) in the acceptance/rejection of analytical method in validation phase. In the context of the harmonization, the other objectives were: (i) to propose a consensus on the norms usually recognized, while widely incorporating the ISO terminology; (ii) to recommend to validate the analytical procedure accordingly to the way it will be used in routine; (iii) to elaborate a rational, practical and statistically reliable strategy to assure the quality of the analytical re

@article{Hubert.2007b, abstract = {As reported in a previous paper, the main objective of the new commission of the Societe Francaise des Sciences et Techniques Pharmaceutiques (SFSTP) was the harmonisation of approaches for the validation of quantitative analytical procedures. In a series of meetings, members of this Commission have first tried to review the objectives of analytical methods and the objectives of validation methods and to recommend the use of two-sided beta-expectation tolerance intervals for total error of validation samples (accuracy profile) in the acceptance/rejection of analytical method in validation phase. In the context of the harmonization, the other objectives were: (i) to propose a consensus on the norms usually recognized, while widely incorporating the ISO terminology; (ii) to recommend to validate the analytical procedure accordingly to the way it will be used in routine; (iii) to elaborate a rational, practical and statistically reliable strategy to assure the quality of the analytical re}, 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. and Rozet, E.}, biburl = {https://www.bibsonomy.org/bibtex/2f689fef0590105c9621e23b33ca94482/kanefendt}, interhash = {75876f54dc080ee873bec597e19c22d7}, intrahash = {f689fef0590105c9621e23b33ca94482}, journal = {J.Pharm.Biomed.Anal.}, keywords = {Analytical Calibration Chemistry Clinical France Laboratories Laboratory Medical Pharmaceutical Reference Reproducibility Research Results Societies Standards Techniques methods of standards}, number = 1, pages = {70-81}, timestamp = {2010-02-05T11:28:57.000+0100}, title = {Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal--part II}, url = {PM:17646076}, volume = 45, year = 2007 }