Application issues in bioanalytical method validation, sample analysis and data reporting

Although some degree of consensus has been reached concerning the requirements for acceptable method validation, the procedures used to establish them vary significantly between laboratories. Also, issues arising from application of these requirements during validation and subsequent sample analysis...

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Bibliographic Details
Published in:Journal of pharmaceutical and biomedical analysis 1995-02, Vol.13 (2), p.89-97
Main Authors: Dadgar, Darioush, Burnett, Pamela E., Gerry Choc, M., Gallicano, Keith, Hooper, John W.
Format: Article
Language:English
Subjects:
Analysis
Animals
Bioanalytical
biofluids
Biological and medical sciences
chromatography
Chromatography - methods
Chromatography - standards
Data Interpretation, Statistical
General pharmacology
Humans
Medical sciences
Pharmacokinetics
Pharmacology. Drug treatments
Reproducibility of Results
stability
validation
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Summary:Although some degree of consensus has been reached concerning the requirements for acceptable method validation, the procedures used to establish them vary significantly between laboratories. Also, issues arising from application of these requirements during validation and subsequent sample analysis need to be addressed. The purpose of this paper is to discuss application issues concerning prerequisites to method validation, and all validation criteria for evaluation of method reliability and overall performance. Other poorly addressed issues such as re-validation, cross-validation, partial sample volume, multicomponent analysis and reporting will also be discussed. Although many issues discussed are of a general nature, the scope of this presentation is primarily to address issues arising from the validation and routine application of chromatographic methods.
ISSN:0731-7085
1873-264X
DOI:10.1016/0731-7085(94)00106-C