Biomarkers and Surrogate Endpoints: Clinical Research and Applications : Proceedings of the NIH-FDA Conference Held on 15-16 April 1999 in Bethesda, Maryland, USA

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Gregory J. Downing
Elsevier, 2000 - Medical - 318 pages
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The potential adaptation of biomarkers as substitutes for clinical endpoints, or surrogate endpoints, in clinical trials has recently taken on new importance. This volume summarizes the proceedings of the first international, multi-disciplinary conference held to discuss this important issue. A historical perspective is provided on the use of biomarkers in drug development, as diagnostic and clinical measuring tools, and in some cases their application as surrogate endpoints in diseases such as AIDS, cancer, and cardiovascular disease. Also included is a review of concepts, terminology, and examples which provide a background for those who are not familiar with the use of biomarkers in drug development and clinical trials.

There is presently no other publication which gives such a unique insight into the current state of understanding of biomarkers for specific disease areas, and the emerging tools and technologies that may be used to discover and evaluate biomarkers. The book also focuses on areas of need or interest in identifying new biomarkers, and key issues for researchers in applying them in drug development and clinical trials.

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ARTICLE LINKS: PDF (72 K) | References (22) | View full-size inline images. British Journal of Clinical Pharmacology:Volume 59(5)May 2005p 491-494 ...
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Company Profile. About Us / Who We Serve · Areas of Expertise · Key Services · Expanded Services · Areas of Consulting ...
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NIH Initiatives in Surrogate Endpoints and Endpoint Analysis
Presented. by. Gregory Downing, Ph.D. at the. Nonclinical Studies Subcommittee. of the. Advisory Committee for Pharmaceutical Science. March 9, 2000 ...
www.fda.gov/ OHRMS/ DOCKETS/ AC/ 00/ slides/ 3593S1_03_downing.ppt

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Biomarkers and Surrogate Endpoints: Clinical Research and Applications
Biomarkers and Surrogate Endpoints: Clinical Research and Applications - Elsevier - 0444503161 - 2000
www.libreriasaulamedica.com/ ficha.asp?id=14950& fam=1& subcat=Psiquiatr%EDa+General

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Editors’ view
DOI:10.1111/j.1365-2125.2005.02435.x. British Journal of Clinical Pharmacology. © 2005 Blackwell Publishing Ltd. Br J Clin Pharmacol ...
www.blackwell-synergy.com/ doi/ pdf/ 10.1111/ j.1365-2125.2005.02435.x

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