Download Accelerating the Development of Biomarkers for Drug Safety: by Institute of Medicine, Board on Health Sciences Policy, PDF

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

Biomarkers might be outlined as signs of any biologic nation, and they're valuable to the way forward for drugs. because the rate of constructing medicines has risen lately, lowering the variety of new medicines licensed to be used, biomarker improvement could be a option to lower expenditures, increase safeguard, and supply a extra targeted 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 safeguard in the course of improvement.

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Development of in Vitro and Other Screening Model Systems In vitro and other screening model systems that could definitively rule out human kidney toxicity caused by test compounds and identify specific kidney toxicities in animal test species would be exceedingly helpful in drug development. Key questions in this area include the following: • • Are such systems viable and close to being established? How can their evolution be fostered, and how can they be efficiently validated? There are several major opportunities for answering these questions: • • • Studying the role and limitations of current primary cell cultures and of embryonic stem cells for assessing new biomarkers.

A critical review of published studies needs to be conducted to identify the most promising new renal biomarkers. If possible, data from these studies should be collected into a usable shared database. Standardized methodologies need to be used for preclinical and clinical data collection, sample collection, histopathology interpretation, biomarker measurements, and data interpretation. These methodologies should reflect the collaborative efforts of experts and vested stakeholders, including sponsors, investigators, and regulatory scientists.

This decrease in activity in area 25 thus appears to be necessary, and possibly sufficient, for the antidepressant response. Perhaps by combining a better understanding of brain circuitry from imaging with genetic and proteomic data, a panel of diverse bio­markers could be developed that would predict responses. NIH supports research to discover potential biomarkers using a variety of approaches. The development and use of biomarkers can contribute to what Insel called the 3D pathway, which stands for discovery, development, and dissemination.

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