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Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls, and study samples

by: W. Nowatzke, and E. Woolf

In: AAPS.J., Vol. 9, Nr. 2 (2007) , p. E117-E122.

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URL:	PM:17614353

Characterization of the stability of analytes in biological samples collected during clinical studies together with that of critical assay reagents, including analyte stock solutions, is recognized as an important component of bioanalytical assay validation. Deficiencies in these areas often come to light during regulatory inspections. Best practices, based on current regulatory guidance, for the assessment of these issues as they pertain to ligand binding and chromatographic assays are covered in this review. Additionally, consensus recommendations reached during the recent AAPS/FDA Workshop on bioanalytical assay validation are highlighted

BibTeX record

@article{Nowatzke.2007,
  abstract = {Characterization of the stability of analytes in biological samples collected during clinical studies together with that of critical assay reagents, including analyte stock solutions, is recognized as an important component of bioanalytical assay validation. Deficiencies in these areas often come to light during regulatory inspections. Best practices, based on current regulatory guidance, for the assessment of these issues as they pertain to ligand binding and chromatographic assays are covered in this review. Additionally, consensus recommendations reached during the recent AAPS/FDA Workshop on bioanalytical assay validation are highlighted},
  added-at = {2010-02-05T11:28:39.000+0100},
  author = {Nowatzke, W. and Woolf, E.},
  biburl = {http://www.bibsonomy.org/bibtex/20aa419dc3c83957f2e585cc89e1b0de1/kanefendt},
  interhash = {1af089df356fc8ab50d250208942907c},
  intrahash = {0aa419dc3c83957f2e585cc89e1b0de1},
  journal = {AAPS.J.},
  keywords = {Animals Binding Biopharmaceutics Chemistry Control Drug Humans Pharmaceutical Pharmacokinetics Preparations Quality Reference Reproducibility Results Solutions Stability Standards analysis deficiency metabolism methods of standards},
  number = 2,
  pages = {E117-E122},
  timestamp = {2010-02-05T11:28:39.000+0100},
  title = {Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls, and study samples},
  url = {PM:17614353},
  volume = 9,
  year = 2007
}

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BibSonomy :: publication ::

Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls, and study samples

Resources (URL, PDF, PS...)

Abstract

BibTeX record

Endnote record