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Accelerating the Development of Biomarkers for Drug Safety

2009-08-20 Medical
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Release : 2009-08-20
Genre : Medical
Kind : eBook
Book Rating : 243/5 ( reviews)

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Book Synopsis Accelerating the Development of Biomarkers for Drug Safety by : Institute of Medicine

Download or read book Accelerating the Development of Biomarkers for Drug Safety written by Institute of Medicine. This book was released on 2009-08-20. Available in PDF, EPUB and Kindle. Book excerpt: Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM's Forum on Drug Discovery, Development, and Translation held "Assessing and Accelerating Development of Biomarkers for Drug Safety," a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development.

Accelerating the Development of Biomarkers for Drug Safety

2009-07-20
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Release : 2009-07-20
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Kind : eBook
Book Rating : 703/5 ( reviews)

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Book Synopsis Accelerating the Development of Biomarkers for Drug Safety by : Forum on Drug Discovery Development and Translation

Download or read book Accelerating the Development of Biomarkers for Drug Safety written by Forum on Drug Discovery Development and Translation. This book was released on 2009-07-20. Available in PDF, EPUB and Kindle. Book excerpt: Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM's Forum on Drug Discovery, Development, and Translation held "Assessing and Accelerating Development of Biomarkers for Drug Safety," a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development.

Improving and Accelerating Therapeutic Development for Nervous System Disorders

2014-02-06 Medical
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Release : 2014-02-06
Genre : Medical
Kind : eBook
Book Rating : 492/5 ( reviews)

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Book Synopsis Improving and Accelerating Therapeutic Development for Nervous System Disorders by : Institute of Medicine

Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine. This book was released on 2014-02-06. Available in PDF, EPUB and Kindle. Book excerpt: Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease

2010-06-25 Medical
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Release : 2010-06-25
Genre : Medical
Kind : eBook
Book Rating : 277/5 ( reviews)

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Book Synopsis Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease by : Institute of Medicine

Download or read book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease written by Institute of Medicine. This book was released on 2010-06-25. Available in PDF, EPUB and Kindle. Book excerpt: Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.

Predictive Approaches in Drug Discovery and Development

2012-02-14 Medical
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Release : 2012-02-14
Genre : Medical
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Book Rating : 264/5 ( reviews)

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Book Synopsis Predictive Approaches in Drug Discovery and Development by : J. Andrew Williams

Download or read book Predictive Approaches in Drug Discovery and Development written by J. Andrew Williams. This book was released on 2012-02-14. Available in PDF, EPUB and Kindle. Book excerpt: Practical Utility of Biomarkers in Drug Discovery and Development covers all aspects of biomarker research applied to drug discovery and development and contains state-of-the-art appraisals on the practical utility of genomic, biochemical, and protein biomarkers. Case histories and lessons from successful and unsuccessful applications of biomarkers are included along with key chapters on GLP validation, safety biomarkers and proteomics biomarkers. Regulatory agency perspectives and initiatives both in the US and internationally are also discussed.

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