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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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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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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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Harmonization of strategies for the validation of quantitative analytical procedures: A SFSTP proposal Part IV. Examples of application
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. 48(3):760-771 (2008)
to Chemistry Chromatography Control Laboratories Quality RANGE Research methods 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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"Matrix effects" in immunoassays
W. G. Wood Scand.J.Clin.Lab Invest Suppl (1991)
to & Antibodies Buffers Control Hormone Humans Immunoassay Parathyroid Quality Reference Standards Thyrotropin blood data methods numerical standards statistics by kanefendt on Feb 5, 2010, 11:28 AM
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Guidelines for immunoassay data processing
R. A. Dudley, P. Edwards, R. P. Ekins, D. J. Finney, I. G. McKenzie, G. M. Raab, D. Rodbard, and R. P. Rodgers Clin.Chem. 31(8):1264-1271 (1985)
to Computers Control Humans Immunoassay Immunologic Laboratories Mathematics Quality Reference Software Techniques Values by kanefendt on Feb 5, 2010, 11:28 AM
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An assessment of the 4-6-20 rule for acceptance of analytical runs in bioavailability, bioequivalence, and pharmacokinetic studies
R. O. Kringle Pharm.Res. 11(4):556-560 (1994)
to Analysis Availability Biological Control Design Equivalency Models Multivariate Pharmacokinetics Quality Research Statistical Therapeutic methods by kanefendt on Feb 5, 2010, 11:28 AM
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Workshop on bioanalytical methods validation for macromolecules: summary report
K. J. Miller, R. R. Bowsher, A. Celniker, J. Gibbons, S. Gupta, J. W. Lee, S. J. Swanson, W. C. Smith, and R. S. Weiner Pharm.Res. 18(9):1373-1383 (2001)
to Assay Biological Chemistry Control Drug Immunoassay Industry Ligands Macromolecular Pharmacokinetics Proteins Quality Recombinant Reproducibility Results Substances metabolism methods of pharmacology protein standards by kanefendt on Feb 5, 2010, 11:28 AM
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