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By Institute of Medicine, Board on Health Sciences Policy, Development, and Translation Forum on Drug Discovery, Robert Giffin, Sally Robinson, Steve Olson

Biomarkers could be outlined as symptoms of any biologic kingdom, and they're imperative to the way forward for medication. because the expense of constructing medications has risen lately, lowering the variety of new medicines authorized to be used, biomarker improvement could be a solution to reduce charges, increase defense, and supply a extra centred and rational pathway to drug improvement. On October 24, 2008, the IOM's discussion board on Drug Discovery, improvement, and Translation held "Assessing and Accelerating improvement of Biomarkers for Drug Safety," a one-day workshop, summarized during this quantity, at the worth of biomarkers in supporting to figure out drug defense in the course of improvement.

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If NIH interprets its role too narrowly, it may not be willing to support clinical research that can have a major impact on patient outcomes. One option would be to convene a standing group including representatives of the National Heart, Lung, and Blood Institute, the FDA, industry, and academia to identify and prioritize high-impact opportunities in terms of public health and to recommend specific targets for research funding. Topics that NIH should consider include technology and animal model development aimed at translation to human studies; development of biomarkers through detailed studies of human 28 DEVELOPMENT OF BIOMARKERS FOR DRUG SAFETY genomics, proteomics, and metabolomics; human studies to validate biomarkers in adequately sized longitudinal studies; and definition of appropriate institutional roles in the development of standards.

Qualified biomarkers of acute kidney toxicity to translate from animals to humans that outperform currently employed functional measures • Once safety biomarkers have been established, qualified biomarkers for kidney toxicity in humans that can predict clinical outcomes, could be used for individual patient dose setting, and could be relied on for assessing the efficacy of interventions • Qualified biomarkers for assessing improvements in kidney involvement as a known comorbidity of underlying disease processes • Translational qualified biomarkers for monitoring kidney safety in animal toxicology studies and early human clinical trials • Translational qualified predictive biomarkers for kidney toxicity in humans that outperform currently employed functional measures for safety monitoring in humans • Qualified kidney safety biomarkers to demonstrate benefits of agents directed against other diseases with kidney comorbidities • changes, and to assess whether the toxicity is species-specific or is relevant to all species, including humans.

Nature Reviews Drug ­Discovery 3:379. Insel, T. 2008. Biomarkers for psychiatric drug toxicity. Speaker presentation at the Institute of Medicine Workshop on Assessing and Accelerating Development of Biomarkers for Drug Safety, October 24, Washington, DC. WHO (World Health Organization). 2002. The world health report 2002: Reducing risks, promoting healthy life. Geneva, Switzerland: WHO. 3 Cardiac Safety Biomarkers In the 1990s, reports of potentially fatal cardiac arrhythmias in adverse event data focused attention on the potential of several drugs to cause cardiac toxicity.

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