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Biomarkers and Surrogate End Points for Fit‐for‐Purpose Development and Regulatory Evaluation of New Drugs
Author(s) -
Wagner JA,
Williams SA,
Webster CJ
Publication year - 2007
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/sj.clpt.6100017
Subject(s) - biomarker , drug development , clinical pharmacology , regulatory science , process (computing) , risk analysis (engineering) , medicine , computer science , drug , computational biology , medical physics , pharmacology , biology , pathology , biochemistry , operating system
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. Clinical Pharmacology & Therapeutics (2007) 81 , 104–107. doi: 10.1038/sj.clpt.6100017