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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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Appropriate calibration curve fitting in ligand binding assays
J. W. Findlay, and R. F. Dillard AAPS.J. 9(2):E260-E267 (2007)
to & Algorithms Analytical Binding Calibration Chemistry Dose-Response Drug Ligands Models Pharmaceutical Pharmacokinetics Preparations Protein RANGE Relationship Reproducibility Research Results Sensitivity Specificity Statistical analysis and data metabolism methods numerical of response statistics by kanefendt on Feb 5, 2010, 11:28 AM
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Fit-for-purpose method development and validation for successful biomarker measurement
J. W. Lee, V. Devanarayan, Y. C. Barrett, R. Weiner, J. Allinson, S. Fountain, S. Keller, I. Weinryb, M. Green, L. Duan, J. A. Rogers, R. Millham, P. J. O'Brien, J. Sailstad, M. Khan, C. Ray, and J. A. Wagner Pharm.Res. 23(2):312-328 (2006)
to Approval Biological Calibration Chemistry Control Data Design Drug Interpretation Markers Models Quality Reproducibility Research Results Statistical Terminology Topic analysis as of 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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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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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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The effects of common matrices for assay standards on performance of ültra sensitive" immunometric assays for TSH. Report of a joint WHO/IFCC collaborative study
R. E. Gaines-Das, H. Brettschneider, and A. F. Bristow Ann.Biol.Clin.Paris 49(10):522-527 (1991)
to Calibration Humans Hyperthyroidism Hypothyroidism Immunoassay Laboratories RANGE Sensitivity Specificity Thyrotropin and blood methods response standards by kanefendt on Feb 5, 2010, 11:28 AM
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The nature of calibrators in immunoassays: are they commutable with test samples? Must they be?
R. Rej, and P. Drake Scand.J.Clin.Lab Invest Suppl (1991)
to & Analysis Calibration Human Humans Immunoassay Laboratories Multivariate Reference Research Standards Thyrotropin analysis blood data numerical standards statistics by kanefendt on Feb 5, 2010, 11:28 AM
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Philosophy of measurement by means of immunoassays
J. Buttner Scand.J.Clin.Lab Invest Suppl (1991)
to Calibration Immunoassay Measures Philosophy Weights and standards by kanefendt on Feb 5, 2010, 11:28 AM
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Determination of parallelism and nonparallelism in bioassay dilution curves
B. D. Plikaytis, P. F. Holder, L. B. Pais, S. E. Maslanka, L. L. Gheesling, and G. M. Carlone J.Clin.Microbiol. 32(10):2441-2447 (1994)
to Analysis Antibodies Assay Bacterial Calibration Enzyme-Linked Haemophilus Humans Immunoassay Immunosorbent Laboratories Neisseria Variance analysis blood immunology influenzae meningitidis of standards by kanefendt on Feb 5, 2010, 11:28 AM
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Bioanalytical method validation for macromolecules in support of pharmacokinetic studies
J. Smolec, B. DeSilva, W. Smith, R. Weiner, M. Kelly, B. Lee, M. Khan, R. Tacey, H. Hill, A. Celniker, V. Shah, R. Bowsher, A. Mire-Sluis, J. W. Findlay, M. Saltarelli, V. Quarmby, D. Lansky, R. Dillard, M. Ullmann, S. Keller, and H. T. Karnes Pharm.Res. 22(9):1425-1431 (2005)
to Analytical Binding Calibration Chemistry Laboratories Pharmacokinetics Reference Reproducibility Results Sensitivity Specificity Standards and methods of by kanefendt on Feb 5, 2010, 11:28 AM
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