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1 Introduction
Pages 1-4

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From page 1...
... Emerging scientific knowledge and technologies hold the potential to enhance correct decision making for the advancement of candidate drugs. Identification of safety problems is a key reason that new drug development is stalled.
From page 2...
... One is the use of various basic sciences, including genomics, metabolomics, pharmacogenomics, and others, to understand the mechanisms underlying toxicity and to predict when a particular compound will have safety issues. The other is the use of new analytical tools for mining large data sets to identify signals that indicate safety problems (e.g., those associated with a class of drugs, those associated with particular molecular entities, or those associated with particular genetic profiles)
From page 3...
... Proposals for fundamental changes in how adverse event data are collected, shared, and analyzed were presented during this part of the workshop. Throughout the workshop, participants emphasized that the ultimate goal of applying these new technologies in safety science is to create a continual, iterative process in which basic scientific data can help inform and predict clinical outcomes, and clinical outcomes can be used to inform and corroborate the basic science.
From page 4...
... • Chapter 9 considers how to integrate the various approaches to safety science and create feedback loops that will allow information to be shared throughout the system. Means of achieving such integration include building interdisciplinary knowledge; creating databases that allow easier identification of associations between compounds and adverse events; understanding the relevance of animal models; and developing "bridging" biomarkers that can bridge, or translate, early preclinical findings to clinical findings.


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