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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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Where is VEGF in the body? A meta-analysis of VEGF distribution in cancer
C. Kut, Gabhann F. Mac, and A. S. Popel Br.J.Cancer 97(7):978-985 (2007)
to A Assay Distribution Endothelial Enzyme-Linked Factor Growth Human Humans Immunosorbent Neoplasms Pharmacokinetics Prognosis Research Tissue Vascular blood cells diagnosis metabolism pathology protein 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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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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Phase I dose escalation study of telatinib, a tyrosine kinase inhibitor of vascular endothelial growth factor receptor 2 and 3, platelet-derived growth factor receptor beta, and c-Kit, in patients with advanced or metastatic solid tumors
F. A. Eskens, N. Steeghs, J. Verweij, J. L. Bloem, O. Christensen, Doorn L. van, J. Ouwerkerk, M. J. Jonge, J. W. Nortier, J. Kraetzschmar, P. Rajagopalan, and H. Gelderblom J.Clin.Oncol. 27(25):4169-4176 (2009)
to & A Administration Adolescent Adult Aged Angiogenesis Biological Contrast Dose Dose-Response Drug Endothelial Factor Factors Fatigue Female Growth Human Humans Hypertension Imaging Inhibitors Kinase Magnetic Male Markers Maximum Media Medical Metastasis Middle Neoplasm Neoplasms Oncology Oral Outcome Pharmacokinetics Plasma Platelet-Derived Protein Proteins Proto-Oncogene Pyridazines Pyridines Receptor Receptor-2 Receptor-3 Relationship Research Resonance Safety Schedule Time Tolerated Treatment Tumor Tyrosine Vascular Young administration adverse antagonists beta blood c-kit diagnostic dosage drug effects enzymology inhibitors methods pathology protein response supply therapy toxicity use by kanefendt on Feb 5, 2010, 11:28 AM
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Pharmacokinetics of sunitinib malate in subjects with hepatic impairment
C. L. Bello, M. Garrett, L. Sherman, J. Smeraglia, B. Ryan, and M. Toh Cancer Chemother.Pharmacol. (2010)
to Pharmacokinetics Research pharmacology by kanefendt on Feb 5, 2010, 11:28 AM
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Vascular endothelial growth factor governs endothelial nitric-oxide synthase expression via a KDR/Flk-1 receptor and a protein kinase C signaling pathway
B. Q. Shen, D. Y. Lee, and T. F. Zioncheck J.Biol.Chem. 274(46):33057-33063 (1999)
to & A Adrenal Animals Aorta C Cattle Cell Cells Cortex Cultured Endothelial Endothelium Enzyme Enzymologic Ester Expression Factor Factors Gene Growth II Inhibitors Kinase Kinases Line Lymphokines Methyl NG-Nitroarginine Nitric Oxide Penicillamine Pharmacokinetics Protein Protein-Tyrosine Proteins Receptor Receptors Recombinant Regulation Signal Substances Synthase Transduction Type Tyrosine Up-Regulation Vascular analogs cells derivatives drug effects metabolism pharmacology protein 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 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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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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A phase 1 study of SU11248 in the treatment of patients with refractory or resistant acute myeloid leukemia AML or not amenable to conventional therapy for the disease
W. Fiedler, H. Serve, H. Dohner, M. Schwittay, O. G. Ottmann, A. M. O'Farrell, C. L. Bello, R. Allred, W. C. Manning, J. M. Cherrington, S. G. Louie, W. Hong, N. M. Brega, G. Massimini, P. Scigalla, W. E. Berdel, and D. K. Hossfeld Blood 105(3):986-993 (2005)
to & 3 Acute Aged Clearance Endothelial Factor Female Follow-Up Genotype Growth Human Humans Hypertension Indoles Kinase Kinases Leukemia Lung Male Metabolic Middle Mutation Myeloid Pharmacokinetics Platelet-Derived Protein-Tyrosine Proteins Proto-Oncogene Pyrroles Rate Receptor Receptors Research SU11248 Studies Tyrosine Vascular analysis antagonists cells drug fms-Like genetics inhibitors protein response therapeutic therapy toxicity use by kanefendt on Feb 5, 2010, 11:28 AM
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Pharmacokinetic profile of cetuximab Erbitux alone and in combination with irinotecan in patients with advanced EGFR-positive adenocarcinoma
C. Delbaldo, J. Y. Pierga, V. Dieras, S. Faivre, V. Laurence, J. C. Vedovato, M. Bonnay, M. Mueser, A. Nolting, A. Kovar, and E. Raymond Eur.J.Cancer 41(12):1739-1745 (2005)
to & Adenocarcinoma Adult Aged Antibodies Antineoplastic Area Assay Camptothecin Chemotherapy Colorectal Combined Curve Enzyme-Linked Epidermal Factor Female Growth Humans Immunosorbent Male Middle Monoclonal Neoplasms Pharmacokinetics Protocols Receptor Research Under administration analogs derivatives dosage drug metabolism therapeutic therapy use by kanefendt on Feb 5, 2010, 11:28 AM
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Prediction of active drug plasma concentrations achieved in cancer patients by pharmacodynamic biomarkers identified from the geo human colon carcinoma xenograft model
F. R. Luo, Z. Yang, H. Dong, A. Camuso, K. McGlinchey, K. Fager, C. Flefleh, D. Kan, I. Inigo, S. Castaneda, T. W. Wong, R. A. Kramer, R. Wild, and F. Y. Lee Clin.Cancer Res. 11(15):5558-5565 (2005)
to Agents Animals Antibodies Antigen Antineoplastic Antitumor Assay Assays Biological Carcinoma Cell Chemistry Colonic Enzyme-Linked Epidermal Factor Factors Female G Growth Human Humans Immunoglobulin Immunohistochemistry Immunosorbent Ki-67 Kinase Line MAP Markers Mice Model Monoclonal Neoplasm Neoplasms Nude Pharmacokinetics Phosphorylation Receptor Research Signaling System Time Transplantation Tumor Tyrosine Xenograft analysis biosynthesis drug metabolism methods pathology pharmacology protein response therapy 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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