%0 Journal Article %1 Findlay.2000 %A Findlay, J. W. %A Smith, W. C. %A Lee, J. W. %A Nordblom, G. D. %A Das, I. %A DeSilva, B. S. %A Khan, M. N. %A Bowsher, R. R. %D 2000 %J J.Pharm.Biomed.Anal. %K Algorithms Antibodies Calibration Control Disease Immunoassay Molecular Progression Quality Reproducibility Results Safety Sensitivity Specificity Weight analysis and metabolism methods of protein response standards %N 6 %P 1249-1273 %T Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective %U PM:10708409 %V 21 %X Immunoassays are bioanalytical methods in which quantitation of the analyte depends on the reaction of an antigen (analyte) and an antibody. Although applicable to the analysis of both low molecular weight xenobiotic and macromolecular drugs, these procedures currently find most consistent application in the pharmaceutical industry to the quantitation of protein molecules. Immunoassays are also frequently applied in such important areas as the quantitation of biomarker molecules which indicate disease progression or regression, and antibodies elicited in response to treatment with macromolecular therapeutic drug candidates. Currently available guidance documents dealing with the validation of bioanalytical methods address immunoassays in only a limited way. This review highlights some of the differences between immunoassays and chromatographic assays, and presents some recommendations for specific aspects of immunoassay validation. Immunoassay calibration curves are inherently nonlinea

@article{Findlay.2000, abstract = {Immunoassays are bioanalytical methods in which quantitation of the analyte depends on the reaction of an antigen (analyte) and an antibody. Although applicable to the analysis of both low molecular weight xenobiotic and macromolecular drugs, these procedures currently find most consistent application in the pharmaceutical industry to the quantitation of protein molecules. Immunoassays are also frequently applied in such important areas as the quantitation of biomarker molecules which indicate disease progression or regression, and antibodies elicited in response to treatment with macromolecular therapeutic drug candidates. Currently available guidance documents dealing with the validation of bioanalytical methods address immunoassays in only a limited way. This review highlights some of the differences between immunoassays and chromatographic assays, and presents some recommendations for specific aspects of immunoassay validation. Immunoassay calibration curves are inherently nonlinea}, added-at = {2010-02-05T11:28:39.000+0100}, author = {Findlay, J. W. and Smith, W. C. and Lee, J. W. and Nordblom, G. D. and Das, I. and DeSilva, B. S. and Khan, M. N. and Bowsher, R. R.}, biburl = {https://www.bibsonomy.org/bibtex/20c75fb6586aa803509dafd38734f0004/kanefendt}, interhash = {4b3d09567f0de230623d42461d03c9b1}, intrahash = {0c75fb6586aa803509dafd38734f0004}, journal = {J.Pharm.Biomed.Anal.}, keywords = {Algorithms Antibodies Calibration Control Disease Immunoassay Molecular Progression Quality Reproducibility Results Safety Sensitivity Specificity Weight analysis and metabolism methods of protein response standards}, number = 6, pages = {1249-1273}, timestamp = {2010-02-05T11:28:46.000+0100}, title = {Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective}, url = {PM:10708409}, volume = 21, year = 2000 }