Biomarker validation : technological, clinical and commercial aspects / edited by Harald Seitz and Sarah Schumacher.

Built on a decade of experience with novel molecular diagnostics, this practice-oriented guide shows how to cope with validation issues during all stages of biomarker development, from the first clinical studies to the eventual commercialization of a new diagnostic test.

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Bibliographic Details
Other Authors: Seitz, Harald (Editor), Schumacher, Sarah (Editor)
Format: eBook
Language:English
Published: Weinheim, Germany : Wiley-VCH, 2015.
Subjects:
Online Access:Click for online access

MARC

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245 0 0 |a Biomarker validation :  |b technological, clinical and commercial aspects /  |c edited by Harald Seitz and Sarah Schumacher. 
264 1 |a Weinheim, Germany :  |b Wiley-VCH,  |c 2015. 
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504 |a Includes bibliographical references and index. 
505 0 |a Related Titles; Title Page; Copyright; Table of Contents; List of Contributors; Chapter 1: Biomarkers -- Past and Future; 1.1 Introduction; 1.2 Definitions of Biomarkers; 1.3 Biomarkers in the Past; 1.4 Novel Molecules and Structural Classes of Biomarkers by New Technologies; 1.5 Biomarkers in Drug Research; 1.7 Summary and Outlook; References; Chapter 2: Quantitative Proteomics Techniques in Biomarker Discovery; 2.1 Introduction; 2.2 2D-Difference Gel Electrophoresis; 2.3 Mass Spectrometry-Based Proteomics; 2.4 MALDI Mass Spectrometry Imaging; 2.5 Conclusion; References. 
505 8 |a Chapter 3: Biomarker Qualification: A Company Point of View3.1 Introduction; 3.2 Biomarker Uses; 3.3 Biomarker Types; 3.4 Validation vs. Qualification; 3.5 Strategic Choices in Business Models; 3.6 Validation of Analytical Methods; 3.7 Clinical Qualification of Candidate Biomarkers; 3.8 Biomarker Qualification in the 'omics Era; 3.9 An Example of a Biomarker Provider; 3.10 Conclusion; References; Chapter 4: Biomarker Discovery and Medical Diagnostic Imaging; 4.1 Introduction; 4.2 Factors to Consider in Biomarker Selection for Imaging. 
505 8 |a 4.3 Defining the Insertion Point of the Assay and Its Business Case4.4 Practical In Vitro Methods Used to Identify Biomarkers; 4.5 Preclinical Models; 4.6 Preclinical Analysis Techniques; 4.7 Translational Considerations and Restrictions; 4.8 Other Uses of Preclinical Models; 4.9 Nuclear Imaging Infrastructure; 4.10 Image Processing; 4.11 Concluding Remarks; References; Chapter 5: Breath: An Often Overlooked Medium in Biomarker Discovery; 5.1 Introduction; 5.2 Breath Analysis Studies: Targets, Techniques, and Approaches; 5.3 Biomarker Confounders; 5.4 Biomarkers in Breath. 
505 8 |a 5.5 Outlook for Breath AnalysisAcknowledgments; References; Chapter 6: HTA in Personalized Medicine Technologies; 6.1 Introduction; 6.2 Health Technology Assessment (HTA); 6.3 Validation and Evaluation of Biomarker Tests; 6.4 Health Technology Assessment of Personalized Medicine Technologies; 6.5 Concluding Remarks; References; Chapter 7: Bone Remodeling Biomarkers: New Actors on the Old Cardiovascular Stage; 7.1 Introduction; 7.2 Cardiovascular Disease and Osteoporosis: Common Risk Factors and Common Pathophysiological Mechanisms; 7.3 Biomarkers of Bone Health in CVD; 7.4 Conclusion. 
520 |a Built on a decade of experience with novel molecular diagnostics, this practice-oriented guide shows how to cope with validation issues during all stages of biomarker development, from the first clinical studies to the eventual commercialization of a new diagnostic test. 
650 0 |a Biochemical markers. 
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