Biomarker Validation - Technological, Clinical & Commercial Aspects [2015] [United VRG] [PDF]

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Description




Biomarker Validation: Technological, Clinical and Commercial Aspects

by Harald Seitz (Editor), Sarah Schumacher (Editor)



• Published Online: 27 FEB 2015 09:48PM EST

• Print ISBN: 9783527337194

• Online ISBN: 9783527680658

• DOI: 10.1002/9783527680658


Description

The term biomarker is a very general one and covers a wide range that includes cells, genes, proteins, hormones, or lipids. The official definition of a biomarker by the NIH (National Institutes of Health, USA) is “A characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention”.

The process of biomarker validation and development includes the discovery phase, clinical study design, qualification, verification, assay optimization, clinical validation, and commercialization of the biomarker(s). The present book deals with all these different aspects and examples of current methods and concepts are given. A complete overview of all methods used today to identify biomarkers and the different kinds of biomarkers that might contribute to better diagnosis and treatment is not the focus of the book. The book rather sheds some light on how biomarkers are validated today, what the common hurdles are, and what can be learned from many years/decades of biomarker research and validation. The book is divided into different sections, addressing among others, technologies for biomarker discovery, clinical trials, and bioinformatics. Finally, future opportunities and trends of biomarkers and the challenges in the future are discussed. We think these different sections deal with the essential aspects of biomarker validation and provide trustworthy data.

This book contains contributions from experts in different fields and from universities as well as research institutes to make sure that varying viewpoints are presented.



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Biomarker Validation - Technological, Clinical & Commercial Aspects [2015] [United VRG] [PDF]