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Biomarkers: Drug Development and Phases in Discovery

Lakshmi Deeraja Manvi Gatta

The success rate of drug development programs is improved by biomarkers and the availability of new therapeutics is thereby accelerated. The production of biomarkers is a multi-step and iterative process that starts with the discovery of biomarkers in samples of diseases and nondiseases. A biomarker could be used as a proxy for a natural outcome. such as survival or permanent morbidity, in assessing possible drug therapies. If the biomarker, which has a direct correlation to better health, is altered by a medication, the biomarker acts as a surrogate endpoint to determine clinical gain.

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