Read e-book online Accelerating the Development of Biomarkers for Drug Safety: PDF

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 could be outlined as signs of any biologic country, and they're valuable to the way forward for medication. because the price of constructing medicines has risen lately, lowering the variety of new medications authorized to be used, biomarker improvement could be a method to lower expenses, improve security, 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 price of biomarkers in assisting to figure out drug safeguard in the course of improvement.

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In zebrafish). Creating partnerships among academia, the pharmaceutical industry, NIH, industry technology providers, and advocacy groups to explore the advancement of in vitro and other model systems for early drug toxicity screening. A Vision of the Future Table 4-2 summarizes a vision of the future for avoiding and addressing kidney safety issues in early drug development. The main features of such a vision are as follows: • In vitro test systems would be available to predict the risk of kidney toxicity, including glomerular and tubule cell injury and functional 38 DEVELOPMENT OF BIOMARKERS FOR DRUG SAFETY TABLE 4-2 Current Deficiencies, Needs, and Proposals to Address Kidney Safety Issues in Early Drug Development Concept Current Needs Future Availability Improved kidney injury biomarkers and kidney toxicity screening systems would help optimize the selection of leading candidates for development and provide for better drug development animal toxicology studies.

Similarly, variants in neurotransmitter receptors can predict some of the variation in response. 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.

Annotation and curation of data are especially important so that data will be usable, standardized, and accessible. Without standardization, it is impossible to look across databases or even different studies and make comparisons or compare outcomes against biomarkers. In addition, patient data need unique identifiers, since frequently it is difficult to identify a patient who took part in more than one CARDIAC SAFETY BIOMARKERS 27 study or developed toxicity after an event. Even drug names need to be better identified, since the trade names of drugs can change.

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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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