%0 Journal Article %1 Lee.2005 %A Lee, J. W. %A Weiner, R. S. %A Sailstad, J. M. %A Bowsher, R. R. %A Knuth, D. W. %A O'Brien, P. J. %A Fourcroy, J. L. %A Dixit, R. %A Pandite, L. %A Pietrusko, R. G. %A Soares, H. D. %A Quarmby, V. %A Vesterqvist, O. L. %A Potter, D. M. %A Witliff, J. L. %A Fritche, H. A. %A O'Leary, T. %A Perlee, L. %A Kadam, S. %A Wagner, J. A. %D 2005 %J Pharm.Res. %K Assay Biological Chemistry Clinical Markers Pharmaceutical Reproducibility Research Results Topic Trials analysis as methods of standards toxicity trends %N 4 %P 499-511 %T Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference report %U PM:15846456 %V 22 %X Biomarkers are increasingly used in drug development to aid scientific and clinical decisions regarding the progress of candidate and marketed therapeutics. Biomarkers can improve the understanding of diseases as well as therapeutic and off-target effects of drugs. Early implementation of biomarker strategies thus promises to reduce costs and time-to-market as drugs proceed through increasingly costly and complex clinical development programs. The 2003 American Association of Pharmaceutical Sciences/Clinical Ligand Assay Society Biomarkers Workshop (Salt Lake City, UT, USA, October 24-25, 2003) addressed key issues in biomarker research, with an emphasis on the validation and implementation of biochemical biomarker assays, covering from preclinical discovery of efficacy and toxicity biomarkers through clinical and postmarketing implementation. This summary report of the workshop focuses on the major issues discussed during presentations and open forums and noted consensus achieved amon

@article{Lee.2005, abstract = {Biomarkers are increasingly used in drug development to aid scientific and clinical decisions regarding the progress of candidate and marketed therapeutics. Biomarkers can improve the understanding of diseases as well as therapeutic and off-target effects of drugs. Early implementation of biomarker strategies thus promises to reduce costs and time-to-market as drugs proceed through increasingly costly and complex clinical development programs. The 2003 American Association of Pharmaceutical Sciences/Clinical Ligand Assay Society Biomarkers Workshop (Salt Lake City, UT, USA, October 24-25, 2003) addressed key issues in biomarker research, with an emphasis on the validation and implementation of biochemical biomarker assays, covering from preclinical discovery of efficacy and toxicity biomarkers through clinical and postmarketing implementation. This summary report of the workshop focuses on the major issues discussed during presentations and open forums and noted consensus achieved amon}, added-at = {2010-02-05T11:28:39.000+0100}, author = {Lee, J. W. and Weiner, R. S. and Sailstad, J. M. and Bowsher, R. R. and Knuth, D. W. and O'Brien, P. J. and Fourcroy, J. L. and Dixit, R. and Pandite, L. and Pietrusko, R. G. and Soares, H. D. and Quarmby, V. and Vesterqvist, O. L. and Potter, D. M. and Witliff, J. L. and Fritche, H. A. and O'Leary, T. and Perlee, L. and Kadam, S. and Wagner, J. A.}, biburl = {https://www.bibsonomy.org/bibtex/2f19ff1a2b74f2d76e334a09a3e7537a3/kanefendt}, interhash = {c57daf45d170fb01e822514388e44269}, intrahash = {f19ff1a2b74f2d76e334a09a3e7537a3}, journal = {Pharm.Res.}, keywords = {Assay Biological Chemistry Clinical Markers Pharmaceutical Reproducibility Research Results Topic Trials analysis as methods of standards toxicity trends}, number = 4, pages = {499-511}, timestamp = {2010-02-05T11:28:42.000+0100}, title = {Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference report}, url = {PM:15846456}, volume = 22, year = 2005 }