Prospective–Retrospective Biomarker Analysis for Regulatory Consideration: white Paper from the Industry Pharmacogenomics Working Group

Abstract excerpt

One approach to delivering cost-effective healthcare requires the identification of patients as individuals or subpopulations that are more likely to respond to an appropriate dose and/or schedule of a therapeutic agent, or as subpopulations that are less likely to develop an adverse event (i.e., personalized or stratified medicine). Biomarkers that identify therapeutically relevant variations in human biology...

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