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The information contained in this section was created by Lawrence K. Oliver, Ph.D.
This article was taken from the Spring 2006 issue of European Pharmaceutical Contractor.
The validation of therapeutic biomarkers in direct patient care is revolutionising drug development.
There is a recognised demand for documentation of the predictive value of results from analysis of endogenous substances showing changes in physiology during trials of new experimental medications. The term ‘biomarker’ was coined several years ago to be applied to these assays, and the definition of the term took numerous iterations over the ensuing period. Whichever definition one follows is not relevant here: all definitions include the concept of predicting some substantive change in the patient’s condition, be it disease regression, disease progression or toxicity assessment. Read more...
This is a web version of an audio/visual presentation.
Biomarkers are a new order of things, with the likelihood of bringing wholesale changes to the practice of medicine. Successful clinical validation of biomarkers for drug development will inevitably lead to the introduction of biomarkers into clinical practice and will thus alter the way medicines are selected, doses are selected, or how patient response is monitored. Read more...
