Accelerating the Development of Biomarkers for Drug Safety: - download pdf or read online

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

ISBN-10: 0309131243

ISBN-13: 9780309131247

Biomarkers might be outlined as signs of any biologic nation, and they're important to the way forward for medication. because the rate of constructing medications has risen lately, lowering the variety of new medicinal drugs authorized to be used, biomarker improvement could be a approach to lower expenditures, improve security, 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 price of biomarkers in aiding to figure out drug safeguard in the course of improvement.

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As there is no way of preventing every drug that proves to have a toxic effect from proceeding into clinical trials, however, definitions and measures of safety must be established. An unintended consequence of biomarker development may be a decrease in the number of available drugs. Once a biomarker has been developed and marketed, it may inhibit the development of drugs if it generates a positive signal that indicates potential future problems. Many companies would hesitate to proceed with the development of such a biomarker, even if there were a poor correlation between the biomarker and toxicity.

Thus far, however, the observed effects of genetic variants have been relatively small. In addition, the predictive power of genomics is limited by the heterogeneity of the disorders being treated and by individual variations in choice of treatment, response, toxicity, and adherence to a therapeutic regime. A key problem has been predicting adverse effects in patients treated with psychiatric drugs. In a study involving 1,742 patients, 120 developed suicidal ideation while receiving antidepressants.

CARDIAC SAFETY BIOMARKERS 19 This chapter begins by describing the regulatory response to the recognition that cardiac events were resulting from adverse reactions to drugs, the responses of drug developers, and effects on physician decision making. This is followed by a review of issues related to the development of potential cardiac safety biomarkers other than QTc, with a particular focus on troponin, and the possible contributions to this work of the Cardiac Safety Research Consortium (CSRC).

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Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary by Institute of Medicine, Board on Health Sciences Policy, Development, and Translation Forum on Drug Discovery, Robert Giffin, Sally Robinson, Steve Olson


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