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Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal--part II
P. 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, and E. Rozet J.Pharm.Biomed.Anal. 45(1):70-81 (2007)
to Analytical Calibration Chemistry Clinical France Laboratories Laboratory Medical Pharmaceutical Reference Reproducibility Research Results Societies Standards Techniques methods of standards by kanefendt on Feb 5, 2010, 11:28 AM
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Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal--part III
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 J.Pharm.Biomed.Anal. 45(1):82-96 (2007)
to & Analytical Calibration Chemistry Clinical France Laboratories Laboratory Medical Pharmaceutical Reference Reproducibility Research Results Societies Standards Techniques data methods numerical of standards statistics by kanefendt on Feb 5, 2010, 11:28 AM
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Key elements of bioanalytical method validation for macromolecules
M. Kelley, and B. DeSilva AAPS.J. 9(2):E156-E163 (2007)
to Antibodies Binding Chemistry Immunoassay Indicators Ligands Macromolecular Monoclonal Pharmaceutical Pharmacokinetics Preparations Reagents Reference Reproducibility Results Sensitivity Specificity Standards Substances analysis and metabolism methods of standards by kanefendt on Feb 5, 2010, 11:28 AM
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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
W. Nowatzke, and E. Woolf AAPS.J. 9(2):E117-E122 (2007)
to Animals Binding Biopharmaceutics Chemistry Control Drug Humans Pharmaceutical Pharmacokinetics Preparations Quality Reference Reproducibility Results Solutions Stability Standards analysis deficiency metabolism methods of standards by kanefendt on Feb 5, 2010, 11:28 AM
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Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays
C. T. Viswanathan, S. Bansal, B. Booth, A. J. DeStefano, M. J. Rose, J. Sailstad, V. P. Shah, J. P. Skelly, P. G. Swann, and R. Weiner Pharm.Res. 24(10):1962-1973 (2007)
to & Administration Animals Artifacts Assay Binding Biological Body Calibration Chemistry Chromatography Control Documentation Drug Fluids Food Government Guidelines Humans Macromolecular Pharmaceutical Quality Radioligand Reference Regulation Reproducibility Research Results Species Specificity Stability Standards States Substances Technology Topic United and as jurisprudence legislation methods of standards by kanefendt on Feb 5, 2010, 11:28 AM
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Critical ligand binding reagent preparation/selection: when specificity depends on reagents
B. Rup, and D. O'Hara AAPS.J. 9(2):E148-E155 (2007)
to Antibodies Binding Chemistry Immunoassay Indicators Ligands Monoclonal Pharmaceutical Pharmacokinetics Preparations Reagents Reproducibility Research Results Safety Sensitivity Specificity and metabolism methods of standards by kanefendt on Feb 5, 2010, 11:28 AM
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Biomarker method validation in anticancer drug development
J. Cummings, T. H. Ward, A. Greystoke, M. Ranson, and C. Dive Br.J.Pharmacol. 153(4):646-656 (2008)
to & Adherence Agents Animals Antineoplastic Assay Biomarkers Cell Clinical Control Death Drug Enzyme-Linked Europe Evaluation Guideline Guidelines Humans Immunosorbent Keratin-18 Laboratories Mass Pharmacological Preclinical Proteins Quality Reproducibility Research Results Spectrometry Terminology Topic Trials analysis as drug effects jurisprudence legislation methods of pharmacology protein standards therapeutic use by kanefendt on Feb 5, 2010, 11:28 AM
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Some important considerations for validation of ligand-binding assays
J. W. Findlay J.Chromatogr.B Analyt.Technol.Biomed.Life Sci. (2008)
to Algorithms Calibration Proteins Reference Standards pharmacology protein standards by kanefendt on Feb 5, 2010, 11:28 AM
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Evaluation of logistic and polynomial models for fitting sandwich-ELISA calibration curves
R. A. Herman, P. N. Scherer, and G. Shan J.Immunol.Methods 339(2):245-258 (2008)
to Assay Calibration Enzyme-Linked Immunosorbent Models Proteins RANGE Theoretical methods protein standards by kanefendt on Feb 5, 2010, 11:28 AM
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Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective
J. W. Findlay, W. C. Smith, J. W. Lee, G. D. Nordblom, I. Das, B. S. DeSilva, M. N. Khan, and R. R. Bowsher J.Pharm.Biomed.Anal. 21(6):1249-1273 (2000)
to Algorithms Antibodies Calibration Control Disease Immunoassay Molecular Progression Quality Reproducibility Results Safety Sensitivity Specificity Weight analysis and metabolism methods of protein response standards by kanefendt on Feb 5, 2010, 11:28 AM
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Human anti-animal antibody interferences in immunological assays
L. J. Kricka Clin.Chem. 45(7):942-956 (1999)
to Animals Antibodies Antibody Body False Fluids Human Humans Immunoassay Laboratories Mice Monoclonal Negative Population Positive RANGE Reactions Specificity analysis immunology methods pathology response standards therapy by kanefendt on Feb 5, 2010, 11:28 AM
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Method dependence of interpretation of immunoassay results
U. H. Stenman, H. Alfthan, and U. Turpeinen Scand.J.Clin.Lab Invest Suppl (1991)
to & Animals Antibodies Antigens Binding Hormones Humans Immunoassay Neoplasm Peptides Protein Sensitivity Specificity analysis and data methods numerical standards statistics by kanefendt on Feb 5, 2010, 11:28 AM
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Calibration is the key to immunoassay but the ideal calibrator is unattainable
J. T. Whicher Scand.J.Clin.Lab Invest Suppl (1991)
to Antibodies Antigens Blood Calibration Humans Immunoassay Peptides Proteins Reference Sensitivity Specificity Standards analysis and blood immunology pathology protein standards by kanefendt on Feb 5, 2010, 11:28 AM
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