Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs.

by: JA Wagner, SA Williams, CJ Webster

Clin Pharmacol Ther, Vol. 81, No. 1. (January 2007), pp. 104-107.

View FullText article

DOI, Nature, Pubmed, Hubmed

Reviews [Write a review of this article]

There are no reviews of this article

Find related articles from these CiteULike users

jyuh, dejori, ic4 (group), generif_paper (group)

Find related articles with these CiteULike tags

biomarker, diagnostics, rct, surrogate

Abstract

A consistent framework for the acceptance and qualification of biomarkers for regulatory use is needed to facilitate innovative and efficient research and subsequent application of biomarkers in drug development. One key activity is biomarker qualification, a graded, "fit-for-purpose" evidentiary process linking a biomarker with biology and clinical end points. A biomarker consortium model will distribute cost and risk, and drive efficient execution of research and ultimately regulatory acceptance of biomarkers for specific indications.

@article{citeulike:1530042, abstract = {A consistent framework for the acceptance and qualification of biomarkers for regulatory use is needed to facilitate innovative and efficient research and subsequent application of biomarkers in drug development. One key activity is biomarker qualification, a graded, "fit-for-purpose" evidentiary process linking a biomarker with biology and clinical end points. A biomarker consortium model will distribute cost and risk, and drive efficient execution of research and ultimately regulatory acceptance of biomarkers for specific indications.}, address = {Merck \& Co. Inc., Rahway, New Jersey, USA. wagner@merck.com}, author = {Wagner, J. A. and Williams, S. A. and Webster, C. J. }, citeulike-article-id = {1530042}, doi = {10.1038/sj.clpt.6100017}, issn = {0009-9236}, journal = {Clin Pharmacol Ther}, keywords = {rct, surrogate}, month = {January}, number = {1}, pages = {104--107}, posted-at = {2007-08-02 10:25:20}, priority = {2}, title = {Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs.}, url = {http://dx.doi.org/10.1038/sj.clpt.6100017}, volume = {81}, year = {2007} }

RIS record

TY - JOUR ID - citeulike:1530042 L3 - citeulike-article-id:1530042 TI - Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs. JF - Clin Pharmacol Ther VL - 81 IS - 1 SP - 104 EP - 107 AD - Merck & Co. Inc., Rahway, New Jersey, USA. wagner@merck.com SN - 0009-9236 N2 - A consistent framework for the acceptance and qualification of biomarkers for regulatory use is needed to facilitate innovative and efficient research and subsequent application of biomarkers in drug development. One key activity is biomarker qualification, a graded, "fit-for-purpose" evidentiary process linking a biomarker with biology and clinical end points. A biomarker consortium model will distribute cost and risk, and drive efficient execution of research and ultimately regulatory acceptance of biomarkers for specific indications. KW - rct KW - surrogate AU - Wagner, JA AU - Williams, SA AU - Webster, CJ PY - 2007/01// UR - http://dx.doi.org/10.1038/sj.clpt.6100017 ER -

RIS BibTeX