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Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal--part III

by: P. Hubert, J. J. Nguyen-Huu, B. Boulanger, E. Chapuzet, N. Cohen, P. A. Compagnon, W. Dewe, M. Feinberg, M. Laurentie, N. Mercier, G. Muzard, L. Valat, and E. Rozet

In: J.Pharm.Biomed.Anal., Vol. 45, Nr. 1 (2007) , p. 82-96.

Resources (URL, PDF, PS...)

URL:	PM:17716847

In the first two documents Ph. Hubert, J.J. Nguyen-Huu, B. Boulanger, E. Chapuzet, P. Chiap, N. Cohen, P.A. Compagnon, W. Dewe, M. Feinberg, M. Lallier, M. Laurentie, N. Mercier, G. Muzard, C. Nivet, L. Valat, J. Pharm. Biomed. Anal. 36 2004 579-586; Ph. Hubert, J.J. Nguyen-Huu, B. Boulanger, E. Chapuzet, P. Chiap, N. Cohen, P.A. Compagnon, W. Dewe, M. Feinberg, M. Lallier, M. Laurentie, N. Mercier, G. Muzard, C. Nivet, L. Valat, E. Rozet, J. Pharm. Biomed. Anal., in press, a recent SFSTP Commission on the validation of analytical procedure has introduced a harmonized approach for the validation of analytical procedures. In order to complete this guide, the statistical methodology allowing to correctly conclude about the validity of a procedure is proposed in this third part of the guide. Indeed all the steps to obtain the decision tool namely the accuracy profile are described and illustrated step by step by a numerical example. This tool, based on the concept of total error bias

BibTeX record

@article{Hubert.2007,
  abstract = {In the first two documents [Ph. Hubert, J.J. Nguyen-Huu, B. Boulanger, E. Chapuzet, P. Chiap, N. Cohen, P.A. Compagnon, W. Dewe, M. Feinberg, M. Lallier, M. Laurentie, N. Mercier, G. Muzard, C. Nivet, L. Valat, J. Pharm. Biomed. Anal. 36 (2004) 579-586; Ph. Hubert, J.J. Nguyen-Huu, B. Boulanger, E. Chapuzet, P. Chiap, N. Cohen, P.A. Compagnon, W. Dewe, M. Feinberg, M. Lallier, M. Laurentie, N. Mercier, G. Muzard, C. Nivet, L. Valat, E. Rozet, J. Pharm. Biomed. Anal., in press], a recent SFSTP Commission on the validation of analytical procedure has introduced a harmonized approach for the validation of analytical procedures. In order to complete this guide, the statistical methodology allowing to correctly conclude about the validity of a procedure is proposed in this third part of the guide. Indeed all the steps to obtain the decision tool namely the accuracy profile are described and illustrated step by step by a numerical example. This tool, based on the concept of total error (bias},
  added-at = {2010-02-05T11:28:39.000+0100},
  author = {Hubert, P. and Nguyen-Huu, J. J. and Boulanger, B. and Chapuzet, E. and Cohen, N. and Compagnon, P. A. and Dewe, W. and Feinberg, M. and Laurentie, M. and Mercier, N. and Muzard, G. and Valat, L. and Rozet, E.},
  biburl = {http://www.bibsonomy.org/bibtex/28bfd52c788e8ee284f85bd2fabadf778/kanefendt},
  interhash = {cad926c00f2719acd14877d3f8873f9c},
  intrahash = {8bfd52c788e8ee284f85bd2fabadf778},
  journal = {J.Pharm.Biomed.Anal.},
  keywords = {& Analytical Calibration Chemistry Clinical France Laboratories Laboratory Medical Pharmaceutical Reference Reproducibility Research Results Societies Standards Techniques data methods numerical of standards statistics},
  number = 1,
  pages = {82-96},
  timestamp = {2010-02-05T11:28:39.000+0100},
  title = {Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal--part III},
  url = {PM:17716847},
  volume = 45,
  year = 2007
}

Endnote record

%0 Journal Article
%1 Hubert.2007
%A Hubert, P.
%A Nguyen-Huu, J. J.
%A Boulanger, B.
%A Chapuzet, E.
%A Cohen, N.
%A Compagnon, P. A.
%A Dewe, W.
%A Feinberg, M.
%A Laurentie, M.
%A Mercier, N.
%A Muzard, G.
%A Valat, L.
%A Rozet, E.
%D 2007
%J J.Pharm.Biomed.Anal.
%K 
%N 1
%P 82-96
%T Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal--part III
%U PM:17716847
%V 45
%X In the first two documents [Ph. Hubert, J.J. Nguyen-Huu, B. Boulanger, E. Chapuzet, P. Chiap, N. Cohen, P.A. Compagnon, W. Dewe, M. Feinberg, M. Lallier, M. Laurentie, N. Mercier, G. Muzard, C. Nivet, L. Valat, J. Pharm. Biomed. Anal. 36 (2004) 579-586; Ph. Hubert, J.J. Nguyen-Huu, B. Boulanger, E. Chapuzet, P. Chiap, N. Cohen, P.A. Compagnon, W. Dewe, M. Feinberg, M. Lallier, M. Laurentie, N. Mercier, G. Muzard, C. Nivet, L. Valat, E. Rozet, J. Pharm. Biomed. Anal., in press], a recent SFSTP Commission on the validation of analytical procedure has introduced a harmonized approach for the validation of analytical procedures. In order to complete this guide, the statistical methodology allowing to correctly conclude about the validity of a procedure is proposed in this third part of the guide. Indeed all the steps to obtain the decision tool namely the accuracy profile are described and illustrated step by step by a numerical example. This tool, based on the concept of total error (bias

BibSonomy :: publication ::

Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal--part III

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Abstract

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Endnote record