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 should be outlined as symptoms of any biologic country, and they're significant to the way forward for drugs. because the price of constructing medicinal drugs has risen lately, lowering the variety of new medications authorized to be used, biomarker improvement could be a strategy to lower expenses, increase 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 aiding to figure out drug defense in the course of improvement.

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Extra resources for Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary

Sample text

The Regulatory Response The recognition that cardiac events were being caused by adverse reactions to drugs led to a variety of regulatory responses. In 1997, the FDA and the International Conference on Harmonisation (ICH) issued Guidance for Industry: S6 Preclinical Safety Evaluation of ­BiotechnologyDerived Pharmaceuticals (FDA, 1997). This was followed in 2001 by Guidance for Industry: S7A Safety Pharmacology Studies for Human Pharmaceuticals (FDA, 2001). Both of these documents stated that cardio­ vascular safety testing should be performed on new drugs, but provided no specific guidance on how this testing should be conducted.

Pdf (accessed October 17, 2008). FDA. 2001. International conference harmonization guidance for industry: S7A safety pharmacology studies for human pharmaceuticals. gov/Cber/gdlns/ichs7a071201. pdf (accessed October 17, 2008). FDA. 2002. The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. Preliminary concept paper. pdf (accessed October 17, 2008). FDA. 2005a. International conference harmonization guidance for industry: E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non­antiarrhythmic drugs.

Pdf (accessed October 17, 2008). Frantz, S. 2004. FDA publishes analysis of the pipeline problem. 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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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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