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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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Surrogate predictive biomarkers for response to anti-EGFR agents: state of the art and challenges
F. Cappuzzo, L. Toschi, G. Finocchiaro, C. Ligorio, and A. Santoro Int.J.Biol.Markers 22(1 Suppl 4):S10-S23 (2007)
to & Antibodies Biological Carcinoma Dosage Drug Epidermal Factor Gene Growth Human Humans Immunohistochemistry Inhibitors Kinase Kinases Lung Markers Monoclonal Mutation Neoplasm Neoplasms Non-Small-Cell Phosphoproteins Predictive Protein Protein-Tyrosine Proteins Proto-Oncogene Quinazolines Receptor Resistance Tests Tyrosine Value analysis antagonists c-akt drug effects erbB-2 erbB-3 genetics identify inhibitors of protein response therapeutic therapy use by kanefendt and 1 other user on Feb 5, 2010, 11:28 AM
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Severe cardiomyopathy in a patient with renal cell carcinoma after treatment with the novel tyrosine kinase inhibitor sunitinib
E. Chorianopoulos, D. Jager, H. A. Katus, and N. Frey Clin.Res.Cardiol. 96(11):829-830 (2007)
to & Aged Agents Angiogenesis Antineoplastic Carcinoma Cardiomyopathies Cell Dysfunction Echocardiography Female Humans Illness Index Indoles Inhibitors Kidney Kinase Kinases Left Neoplasms Protein-Tyrosine Pyrroles Renal Severity Tyrosine Ventricular adverse antagonists chemically contraindications drug effects induced inhibitors of therapy 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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Isolation and enumeration of circulating endothelial cells by immunomagnetic isolation: proposal of a definition and a consensus protocol
A. Woywodt, A. D. Blann, T. Kirsch, U. Erdbruegger, N. Banzet, M. Haubitz, and F. gnat George J.Thromb.Haemost. 4(3):671-677 (2006)
to Antigens CD146 Cell Cells Chemistry Count Diseases Endothelial Humans Immunomagnetic Immunophenotyping Lectins Plant Reproducibility Results Separation Size Vascular analysis cells immunology methods of pathology 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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Circulating lymphangiogenic growth factors in gastrointestinal solid tumors, could they be of any clinical significance?
T. D. Tsirlis, G. Papastratis, K. Masselou, C. Tsigris, A. Papachristodoulou, A. Kostakis, and N. I. Nikiteas World J.Gastroenterol. 14(17):2691-2701 (2008)
to Biological C Chain Colorectal D Endothelial Esophageal Factor Gastrointestinal Growth Human Humans Immunohistochemistry Inflammation Ligands Lymphangiogenesis Lymphatic Markers Metastasis Neoplasm Neoplasms Polymerase Predictive Prognosis Reaction Receptor-3 Staging Stomach System Tests Tumor Value Vascular Vessels blood metabolism mortality of pathology physiopathology surgery by kanefendt on Feb 5, 2010, 11:28 AM
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VEGFR-3 expression is restricted to blood and lymphatic vessels in solid tumors
T. V. Petrova, P. Bono, W. Holnthoner, J. Chesnes, B. Pytowski, H. Sihto, P. Laakkonen, P. Heikkila, H. Joensuu, and K. Alitalo Cancer Cell 13(6):554-556 (2008)
to Antibodies Antibody Blood Blotting Cell Cells Chain Chemistry Cytometry Endothelial Factor Flow Growth Humans Immunohistochemistry Line Lymphatic Messenger Neoplasms Northern Polymerase RNA Reaction Receptor-3 Reproducibility Results Reverse Separation Specificity Transcriptase Tumor Vascular Vessels Western analysis blood genetics immunology methods of pathology supply 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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Optimizing the use of biomarkers, surrogate endpoints, and clinical endpoints for more efficient drug development
W. A. Colburn J.Clin.Pharmacol. 40(12 Pt 2):1419-1427 (2000)
to Biological Design Dose-Response Drug Factors Forecasting Humans Laboratories Markers Pharmacokinetics Relationship Reproducibility Results Time analysis drug of therapy by kanefendt on Feb 5, 2010, 11:28 AM
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Bioanalytical method validation--a revisit with a decade of progress
V. P. Shah, K. K. Midha, J. W. Findlay, H. M. Hill, J. D. Hulse, I. J. McGilveray, G. McKay, K. J. Miller, R. N. Patnaik, M. L. Powell, A. Tonelli, C. T. Viswanathan, and A. Yacobi Pharm.Res. 17(12):1551-1557 (2000)
to Assay Availability Biological Equivalency Indicators Pharmaceutical Pharmacokinetics Preparations Reagents Reproducibility Research Results Therapeutic analysis and of by kanefendt on Feb 5, 2010, 11:28 AM
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An analysis of the Washington Conference Report on bioanalytical method validation
C. Hartmann, D. L. Massart, and R. D. McDowall J.Pharm.Biomed.Anal. 12(11):1337-1343 (1994)
to Analytical Chemistry Guidelines Reproducibility Results Statistics Terminology Topic analysis as methods of 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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