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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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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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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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