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| home > ebr > summer 2003 > how to include genetic analysis in clinical trials |
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European BioPharmaceutical Review
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| The demand for genetic analysis in clinical trials is increasing. This is partly due to the growing realisation that understanding the genetic variation within a clinical trial population can improve the design, safety and outcome of the trial. A second major driver is the encouragement that the regulatory authorities, in particular the FDA, are giving to the inclusion of a pharmacogenomic element. For the pharmaceutical company or CRO wishing to incorporate a genetic analysis component there are now a number of service providers who have both the technical ability and appropriate quality systems to provide clinical trial grade genotyping. |
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