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Method validation in the bioanalytical laboratory

by: A. R. Buick, M. V. Doig, S. C. Jeal, G. S. Land, and R. D. McDowall

In: J.Pharm.Biomed.Anal., Vol. 8, Nr. 8-12 (1990) , p. 629-637.

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URL:	PM:2100599

Bioanalytical methods, based on a variety of physico-chemical and biological techniques such as chromatography, immunoassay and mass spectrometry, must be validated prior to and during use to engender confidence in the results generated. The fundamental criteria for assessing the reliability and overall performance of a bioanalytical method are: the evaluation of drug and analyte stability, selectivity, limits of quantification and detection, accuracy, precision, linearity and recovery. The extent to which a method is validated is dependent on its prospective use, the number of samples to be assayed and the use to which the data are put. Specific analytical techniques may require additional validation such as antibody-binding characteristics, peak purity determination, evaluation of matrix effects or structural confirmation of the analyte. Ideally each assay should be cross-validated with a method utilizing a highly specific detector such as a mass spectrometer. Once in use, the perfor

BibTeX record

@article{Buick.1990,
  abstract = {Bioanalytical methods, based on a variety of physico-chemical and biological techniques such as chromatography, immunoassay and mass spectrometry, must be validated prior to and during use to engender confidence in the results generated. The fundamental criteria for assessing the reliability and overall performance of a bioanalytical method are: the evaluation of drug and analyte stability, selectivity, limits of quantification and detection, accuracy, precision, linearity and recovery. The extent to which a method is validated is dependent on its prospective use, the number of samples to be assayed and the use to which the data are put. Specific analytical techniques may require additional validation such as antibody-binding characteristics, peak purity determination, evaluation of matrix effects or structural confirmation of the analyte. Ideally each assay should be cross-validated with a method utilizing a highly specific detector such as a mass spectrometer. Once in use, the perfor},
  added-at = {2010-02-05T11:28:39.000+0100},
  author = {Buick, A. R. and Doig, M. V. and Jeal, S. C. and Land, G. S. and McDowall, R. D.},
  biburl = {http://www.bibsonomy.org/bibtex/27d8f63526ca309fba067dc4403b15c54/kanefendt},
  interhash = {55d048da5ff455da59e3137fe3b8cfd0},
  intrahash = {7d8f63526ca309fba067dc4403b15c54},
  journal = {J.Pharm.Biomed.Anal.},
  keywords = {Chemistry Drug Freezing Mass Pharmaceutical Reference Research Solubility Species Specificity Spectrometry Stability Standards Temperature instrumentation methods standards},
  number = {8-12},
  pages = {629-637},
  timestamp = {2010-02-05T11:28:39.000+0100},
  title = {Method validation in the bioanalytical laboratory},
  url = {PM:2100599},
  volume = 8,
  year = 1990
}

Endnote record

%0 Journal Article
%1 Buick.1990
%A Buick, A. R.
%A Doig, M. V.
%A Jeal, S. C.
%A Land, G. S.
%A McDowall, R. D.
%D 1990
%J J.Pharm.Biomed.Anal.
%K 
%N 8-12
%P 629-637
%T Method validation in the bioanalytical laboratory
%U PM:2100599
%V 8
%X Bioanalytical methods, based on a variety of physico-chemical and biological techniques such as chromatography, immunoassay and mass spectrometry, must be validated prior to and during use to engender confidence in the results generated. The fundamental criteria for assessing the reliability and overall performance of a bioanalytical method are: the evaluation of drug and analyte stability, selectivity, limits of quantification and detection, accuracy, precision, linearity and recovery. The extent to which a method is validated is dependent on its prospective use, the number of samples to be assayed and the use to which the data are put. Specific analytical techniques may require additional validation such as antibody-binding characteristics, peak purity determination, evaluation of matrix effects or structural confirmation of the analyte. Ideally each assay should be cross-validated with a method utilizing a highly specific detector such as a mass spectrometer. Once in use, the perfor

BibSonomy :: publication ::

Method validation in the bioanalytical laboratory

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Abstract

BibTeX record

Endnote record