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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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Sunitinib efficacy against advanced renal cell carcinoma
R. J. Motzer, M. D. Michaelson, J. Rosenberg, R. M. Bukowski, B. D. Curti, D. J. George, G. R. Hudes, B. G. Redman, K. A. Margolin, and G. Wilding J.Urol. 178(5):1883-1887 (2007)
to & Administration Adult Aged Agents Antineoplastic Carcinoma Cell Disease Disease-Free Female Follow-Up Humans Indoles Kidney Laboratories Male Method Middle Neoplasm Neoplasms Oral Outcome Progression Pyrroles Rate Renal Research Retrospective Single-Blind Staging States Studies Survival Treatment Tyrosine United administration dosage drug epidemiology methods mortality pathology response therapy 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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Cardiotoxicity associated with tyrosine kinase inhibitor sunitinib
T. F. Chu, M. A. Rupnick, R. Kerkela, S. M. Dallabrida, D. Zurakowski, L. Nguyen, K. Woulfe, E. Pravda, F. Cassiola, J. Desai, S. George, J. A. Morgan, D. M. Harris, N. S. Ismail, J. H. Chen, F. J. Schoen, A. D. van den Abbeele, G. D. Demetri, T. Force, and M. H. Chen Lancet 370(9604):2011-2019 (2007)
to & Aged Agents Animals Antineoplastic Arteries Artery Blood Carcinoma Coronary Disease Failure Female Gastrointestinal Heart Humans Hypertension Indoles Kinase Kinases Male Mice Middle Multicenter Pressure Protein-Tyrosine Pyrroles Rats Research Retrospective Safety Stroke Stromal Studies Topic Tumors Tyrosine Volume adverse antagonists as blood chemically drug effects induced inhibitors methods therapeutic therapy toxicity use by kanefendt on Feb 5, 2010, 11:28 AM
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Surrogate biomarkers in evaluating response to anti-angiogenic agents: focus on sunitinib
S. E. Deprimo, and C. Bello Ann.Oncol (2007)
to Angiogenesis Biological Cells Endothelial Growth Humans Indoles Inhibitors Laboratories Markers Neoplasms Neovascularization Pathologic Proteins Pyrroles Research Tumor blood cells diagnosis drug effects metabolism methods pathology pharmacology protein response supply therapeutic therapy use 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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Vascular endothelial growth factor-D and its receptor VEGFR-3: two novel independent prognostic markers in gastric adenocarcinoma
S. Juttner, C. Wissmann, T. Jons, M. Vieth, J. Hertel, S. Gretschel, P. M. Schlag, W. Kemmner, and M. Hocker J.Clin.Oncol. 24(2):228-240 (2006)
to 80 Adenocarcinoma Adult Aged Antibodies C Cell Chemistry D Disease-Free Endothelial Factor Growth Humans Immunohistochemistry Laboratories Line Lymphatic Messenger Metastasis Middle Neoplasms Prognosis RNA Receptor-3 Research Stomach Survival Tumor Vascular analysis and blood genetics identify methods mortality over supply by kanefendt on Feb 5, 2010, 11:28 AM
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Measurement of plasma levels of vascular endothelial growth factor in prostate cancer patients: relationship with clinical stage, Gleason score, prostate volume, and serum prostate-specific antigen
J. L. Duque, K. R. Loughlin, R. M. Adam, P. Kantoff, E. Mazzucchi, and M. R. Freeman Clinics. 61(5):401-408 (2006)
to 80 A Adult Age Aged Antigen Biological Case-Control Distribution Endothelial Factor Growth Humans Immunoassay Male Markers Middle Neoplasm Neoplasms Nonparametric Organ Population Prognosis Prostate Prostate-Specific Prostatic Retrospective Size Staging Statistics Studies Tumor Vascular and blood methods over pathology physiology 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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Effects of aspirin on intra-platelet vascular endothelial growth factor, angiopoietin-1, and p-selectin levels in hypertensive patients
S. Nadar, A. D. Blann, and G. Y. Lip Am.J.Hypertens. 19(9):970-977 (2006)
to A Activation Aged Aggregation Angiopoietin-1 Aspirin Biological Blood Case-Control Count Cyclooxygenase Endothelial England Factor Female Follow-Up Growth Humans Hypertension Immunoassay Inhibitors Longitudinal Male Markers Middle Outcome P-Selectin Platelet Platelets Pressure Research Studies Thrombosis Treatment Vascular blood drug effects metabolism methods pharmacology physiopathology therapeutic therapy use by kanefendt on Feb 5, 2010, 11:28 AM
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Circulating VEGF reduction, response and outcome in advanced colorectal cancer patients treated with cetuximab plus irinotecan
B. Vincenzi, D. Santini, A. Russo, M. Gavasci, F. Battistoni, G. Dicuonzo, L. Rocci, V. M. Rosaria, N. Gebbia, and G. Tonini Pharmacogenomics. 8(4):319-327 (2007)
to & A Adult Aged Antibodies Antineoplastic Biological Camptothecin Chemotherapy Colorectal Combined Disease Endothelial Factor Female Growth Humans Male Markers Medical Middle Monoclonal Neoplasms Oncology Outcome Progression Prospective Protocols Rate Studies Survival Treatment Tumor Vascular administration analogs antagonists blood derivatives dosage drug inhibitors methods mortality response therapeutic therapy trends use 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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Workshop/Conference Report - Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand binding Assays
Bansal SBooth BDeStefano AJRose MJSailstad JShah VPSkelly JPSwann PGWeiner R. Viswanathan CT The AAPS Journal 9(1):E30-E42 (2007)
to Binding Ligand assays binding methods by kanefendt on Feb 5, 2010, 11:28 AM
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Effect of treatment with sunitinib malate, a multitargeted tyrosine kinase inhibitor, on circulating plasma levels of VEGF, soluble VEGF receptors 2 and 3, and soluble KIT in patients with metastatic breast cancer
S. E. Deprimo, C. Friece, X. Huang, J. Smeraglia, L. Sherman, M. Collier, C. Baum, A. D. Elias, H. J. Burstein, and K. D. Miller J Clin Oncol Meeting Abstracts 24(18_suppl):578 (2006)
to Outcome Proteins Research SU11248 Treatment Tyrosine analysis methods protein response therapy by kanefendt on Feb 5, 2010, 11:28 AM
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Validation of analytic methods for biomarkers used in drug development
C. H. Chau, O. Rixe, H. McLeod, and W. D. Figg Clin.Cancer Res. 14(19):5967-5976 (2008)
to Agents Animals Antineoplastic Biological Biomarkers Chemistry Design Drug Evaluation Genome Genomics Human Humans Markers Medical Mice Neoplasms Oncology Outcome Pharmaceutical Pharmacological Preclinical Research Treatment Tumor analysis drug metabolism methods pharmacology therapy 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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Phase II study of sunitinib malate, an oral multitargeted tyrosine kinase inhibitor, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane
H. J. Burstein, A. D. Elias, H. S. Rugo, M. A. Cobleigh, A. C. Wolff, P. D. Eisenberg, M. Lehman, B. J. Adams, C. L. Bello, S. E. Deprimo, C. M. Baum, and K. D. Miller J Clin Oncol 26(11):1810-1816 (2008)
to & Administration Adult Aged Agents Anthracyclines Antineoplastic Biological Breast Bridged Carcinoma Chemotherapy Combined Compounds Diseases Drug Fatigue Female Gastrointestinal Growth Hematologic Humans Indoles Inflammation Kinase Kinases Markers Middle Neoplasms Oral Plasma Protein-Tyrosine Protocols Pyrroles Rate Schedule Survival Taxoids Tumor Tyrosine administration adverse analysis antagonists blood chemically classification dosage drug effects induced inhibitors methods mortality response secondary therapeutic therapy use by kanefendt on Feb 5, 2010, 11:28 AM
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