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

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" evid...

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Bibliographic Details
Published inClinical pharmacology and therapeutics Vol. 81; no. 1; p. 104
Main Authors Wagner, J A, Williams, S A, Webster, C J
Format Journal Article
LanguageEnglish
Published United States 01.01.2007
Subjects
Biomarkers
Decision Making
Drug Evaluation - methods
Endpoint Determination
Humans
Reproducibility of Results
Research Design
Treatment Outcome
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Summary: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.
ISSN:0009-9236
DOI:10.1038/sj.clpt.6100017