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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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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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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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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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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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Method validation in the bioanalytical laboratory
A. R. Buick, M. V. Doig, S. C. Jeal, G. S. Land, and R. D. McDowall J.Pharm.Biomed.Anal. 8(8-12):629-637 (1990)
to Chemistry Drug Freezing Mass Pharmaceutical Reference Research Solubility Species Specificity Spectrometry Stability Standards Temperature instrumentation methods 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 I
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, and L. Valat J.Pharm.Biomed.Anal. 36(3):579-586 (2004)
to Analytical Chemistry Clinical France Laboratory Medical Pharmaceutical Reproducibility Results Societies Techniques diagnosis methods of standards by kanefendt on Feb 5, 2010, 11:28 AM
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Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies
D. Geng, G. Shankar, A. Schantz, M. Rajadhyaksha, H. Davis, and C. Wagner J.Pharm.Biomed.Anal. 39(3-4):364-375 (2005)
to Animals Antibodies Assay Chemistry Drug Enzyme-Linked Humans Immunoassay Immunoenzyme Immunosorbent Industry Monoclonal Pharmaceutical Preparations Reproducibility Research Results Sensitivity Specificity Techniques analysis and methods of pharmacology protein by kanefendt on Feb 5, 2010, 11:28 AM
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Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference report
J. W. Lee, R. S. Weiner, J. M. Sailstad, R. R. Bowsher, D. W. Knuth, P. J. O'Brien, J. L. Fourcroy, R. Dixit, L. Pandite, R. G. Pietrusko, H. D. Soares, V. Quarmby, O. L. Vesterqvist, D. M. Potter, J. L. Witliff, H. A. Fritche, T. O'Leary, L. Perlee, S. Kadam, and J. A. Wagner Pharm.Res. 22(4):499-511 (2005)
to Assay Biological Chemistry Clinical Markers Pharmaceutical Reproducibility Research Results Topic Trials analysis as methods of standards toxicity trends by kanefendt on Feb 5, 2010, 11:28 AM
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Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules
B. DeSilva, W. Smith, R. Weiner, M. Kelley, J. Smolec, B. Lee, M. Khan, R. Tacey, H. Hill, and A. Celniker Pharm.Res. 20(11):1885-1900 (2003)
to Assay Binding Carrier Europe Ligands Macromolecular Pharmaceutical Preparations Proteins Radioligand Reproducibility Research Results States Substances United metabolism methods of protein standards by kanefendt on Feb 5, 2010, 11:28 AM
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