Fit-for-purpose method development and validation for successful biomarker measurement.

@article{citeulike:712017, abstract = {Despite major advances in modern drug discovery and development, the number of new drug approvals has not kept pace with the increased cost of their development. Increasingly, innovative uses of biomarkers are employed in an attempt to speed new drugs to market. Still, widespread adoption of biomarkers is impeded by limited experience interpreting biomarker data and an unclear regulatory climate. Key differences preclude the direct application of existing validation paradigms for drug analysis to biomarker research. Following the AAPS 2003 Biomarker Workshop (J. W. Lee, R. S. Weiner, J. M. Sailstad, et al. Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development. A conference report. Pharm Res 22:499-511, 2005), these and other critical issues were addressed. A practical, iterative, "fit-for-purpose" approach to biomarker method development and validation is proposed, keeping in mind the intended use of the data and the attendant regulatory requirements associated with that use. Sample analysis within this context of fit-for-purpose method development and validation are well suited for successful biomarker implementation, allowing increased use of biomarkers in drug development.}, address = {Formerly MDS Pharma Services, Lincoln, Nebraska, USA. jwlee@amgen.com}, author = {Lee, J. W. and Devanarayan, V. and Barrett, Y. C. and Weiner, R. and Allinson, J. and Fountain, S. and Keller, S. and Weinryb, I. and Green, M. and Duan, L. and Rogers, J. A. and Millham, R. and O'Brien, P. J. and Sailstad, J. and Khan, M. and Ray, C. and Wagner, J. A. }, citeulike-article-id = {712017}, issn = {0724-8741}, journal = {Pharm Res}, keywords = {biomarkers}, month = {February}, number = {2}, pages = {312--328}, posted-at = {2006-06-27 06:18:01}, priority = {4}, title = {Fit-for-purpose method development and validation for successful biomarker measurement.}, url = {http://dx.doi.org/10.1007/s11095-005-9045-3}, volume = {23}, year = {2006} }

TY - JOUR ID - citeulike:712017 L3 - citeulike-article-id:712017 TI - Fit-for-purpose method development and validation for successful biomarker measurement. JF - Pharm Res VL - 23 IS - 2 SP - 312 EP - 328 AD - Formerly MDS Pharma Services, Lincoln, Nebraska, USA. jwlee@amgen.com SN - 0724-8741 N2 - Despite major advances in modern drug discovery and development, the number of new drug approvals has not kept pace with the increased cost of their development. Increasingly, innovative uses of biomarkers are employed in an attempt to speed new drugs to market. Still, widespread adoption of biomarkers is impeded by limited experience interpreting biomarker data and an unclear regulatory climate. Key differences preclude the direct application of existing validation paradigms for drug analysis to biomarker research. Following the AAPS 2003 Biomarker Workshop (J. W. Lee, R. S. Weiner, J. M. Sailstad, et al. Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development. A conference report. Pharm Res 22:499-511, 2005), these and other critical issues were addressed. A practical, iterative, "fit-for-purpose" approach to biomarker method development and validation is proposed, keeping in mind the intended use of the data and the attendant regulatory requirements associated with that use. Sample analysis within this context of fit-for-purpose method development and validation are well suited for successful biomarker implementation, allowing increased use of biomarkers in drug development. KW - biomarkers AU - Lee, JW AU - Devanarayan, V AU - Barrett, YC AU - Weiner, R AU - Allinson, J AU - Fountain, S AU - Keller, S AU - Weinryb, I AU - Green, M AU - Duan, L AU - Rogers, JA AU - Millham, R AU - O'Brien, PJ AU - Sailstad, J AU - Khan, M AU - Ray, C AU - Wagner, JA PY - 2006/02// UR - http://dx.doi.org/10.1007/s11095-005-9045-3 ER -