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" Biomarker validation : "
edited by Harald Seitz and Sarah Schumacher
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BL
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650193
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dltt
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Biomarker validation : : technological, clinical and commercial aspects /\ edited by Harald Seitz and Sarah Schumacher
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1 online resource
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| ISBN
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9783527680658
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: 3527680659
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: 9783527680665
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: 3527680667
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9783527337194
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: 3527337199
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: 9783527337194
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: 9783527680672 (Epub)
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: 3527680675 (Epub)
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: 9783527680689 (mobi)
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: 3527680683 (mobi)
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| Bibliographies/Indexes
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Includes bibliographical references and index
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| Contents
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Biomarkers - Past and Future / Siegfried Neumann -- Introduction -- Definitions of Biomarkers -- Biomarkers in the Past -- Novel Molecules and Structural Classes of Biomarkers by New Technologies -- Biomarkers in Drug Research -- Current Development and Future Trends for Biomarkers in Laboratory Diagnostics -- Biomarker Test Validation -- Companion Diagnostics in Clinical Pharmacology -- Biomarker Multivariate Index Assays -- Regulatory Policies on Biomarker Tests -- Summary and Outlook -- References -- Quantitative Proteomics Techniques in Biomarker Discovery / Thilo Bracht, Dominik Andre Megger, Wael Naboulsi, Corinna Henkel, Barbara Sitek -- Introduction -- General Considerations -- 2D-DifFerence Gel Electrophoresis -- Mass Spectrometry-Based Proteomics -- Principles and Instrumentation -- Ionization Methods -- Mass Analyzers -- Label-Free Protein Quantification -- Area Under Curve (AUC) or Signal Intensity Measurement -- Spectral Counting -- Label-Based Proteome Analysis -- MALDI Mass Spectrometry Imaging -- Conclusion -- References -- Biomarker Qualification: A Company Point of View / Maximilian Breitner, Kaïdre Bendjama, Hüseyin Firat -- Introduction -- Biomarker Uses -- Biomarker Types -- Validation vs. Qualification -- Strategic Choices in Business Models -- Validation of Analytical Methods -- Currently Applicable Guidelines for the Validation of Analytical Methods -- Laboratory Proficiency -- Establishment of Reference Ranges for Candidate Biomarkers -- Clinical Qualification of Candidate Biomarkers -- Methodological Approaches -- Study Size for Biomarker Performance Characterization -- Sample Quality and Biobanking -- Sample Collection -- Storage of Sample -- Clinical Data (Sample Annotation) -- Ethical Considerations -- Biomarker Qualification in the 'omics Era -- An Example of a Biomarker Provider -- Conclusion -- References -- Biomarker Discovery and Medical Diagnostic Imaging / Andreas P. Sakka, James R. Whiteside -- Introduction -- Imaging Modalities -- Positron Emission Tomography (PET) -- Single Photon Emission Computed Tomography (SPECT) -- Computed Tomography (CT) -- Magnetic Resonance Imaging (MRI) -- Ultrasound (US) -- Factors to Consider in Biomarker Selection for Imaging -- Defining the Insertion Point of the Assay and Its Business Case -- Practical In Vitro Methods Used to Identify Biomarkers -- Preclinical Models -- Model Species -- Inducing Human Disease and Relevant Biomarker Expression -- Genetic Manipulation -- Pharmacological/Chemical Induction -- Xenografts: Grafting Foreign Cells or Tissues -- Physical Induction -- Preclinical Analysis Techniques -- Translational Considerations and Restrictions -- Other Uses of Preclinical Models -- Nuclear Imaging Infrastructure -- Image Processing -- Concluding Remarks -- References -- Breath: An Often Overlooked Medium in Biomarker Discovery / Jonathan D Beauchamp, Joachim D Pleil -- Introduction -- Breath Analysis: Past and Present -- Breath Analysis Studies: Targets, Techniques, and Approaches -- Exhaled Breath Gas, Condensate, and Aerosols -- Sampling Techniques and Analytical Tools -- Discovery Versus Targeted Study Approaches -- Biomarker Confounders -- Sampling Impact -- Online Breath Sampling and Direct Analysis -- Breath Sampling for Offline Analysis -- Contributions from the Exposome -- Biomarkers in Breath -- Inorganic Breath Biomarkers -- Organic Biomarkers in Breath -- Outlook for Breath Analysis -- Acknowledgments -- References -- HTA in Personalized Medicine Technologies / Franz Hessel -- Introduction -- Health Technology Assessment (HTA) -- Validation and Evaluation of Biomarker Tests -- Health Technology Assessment of Personalized Medicine Technologies -- Concluding Remarks -- References -- Bone Remodeling Biomarkers: New Actors on the Old Cardiovascular Stage / Cristina Vassalle, Silvia Maffei, Giorgio lervasi -- Introduction -- Cardiovascular Disease and Osteoporosis: Common Risk Factors and Common Pathophysiological Mechanisms -- Biomarkers of Bone Health in CVD -- Cathepsin K -- Tartrate-Resistant Acid Phosphatase -- Sclerostin -- Fibroblast Growth Factor 23 -- Osteopontin -- Osteocalcin -- Osteoprotegerin -- Vitamin D -- Other Factors -- Genetic Factors -- Conclusion -- References -- Identification and Validation of Breast Cancer Biomarkers / Kori Jackson, Edward Sauter -- Introduction -- Current Detection and Treatment Modalities -- Detection: In Clinical Use -- Physical Examination -- Breast Imaging -- Detection: Being Evaluated -- Bodily Fluid Analyses -- Treatment: In Clinical Use -- Surgery and Radiation ISO -- Systemic Therapy -- Treatment: Being Evaluated/Newly Available -- Biomarkers in Tissue: Single Markers -- Biomarkers in Tissue: Gene Panels -- Current Biomarker Limitations -- Tumor Heterogeneity -- Treatment Effect -- Primary Versus Recurrent Tumor -- Future Biomarker Discovery Targets -- Autoantibodies -- Inflammatory Markers -- DNA Methylation -- Benign Breast Disease -- Pregnancy-Associated Breast Cancer -- Challenges with New Biomarker Development and Validation -- Sample Type Selection for Validation Studies of Diagnostic Biomarkers -- Why Ductal Lavage for DNA Analysis? -- Why Nipple Aspirate Fluid for Protein Analysis? -- Why Circulating Samples for Protein Analysis? -- DNA Candidates -- RNA Candidates -- Protein Candidates -- Summary -- References -- Evaluation of Proteomic Data: From Profiling to Network Analysis by Way of Biomarker Discovery / Dado Di Silvestre, Francesco Brambilla, Sara Motta, Pierluigi Mauri -- Introduction -- Proteomic Methodologies -- Shotgun Proteomics -- Targeted Proteomics -- Data-Independent Acquisition (DIA) MS -- Biomarker Discovery -- MudPIT Data Processing -- Protein-Protein Interaction Network Analysis -- Conclusion -- References -- Biomarkers: From Discovery to Commercialization / Sebastian Hoppe, Henry Memczak -- Comparison of Different Platforms -- Mass Spectrometry -- Enzyme-Linked Immunosorbent Assay -- SPR Imaging -- Reverse Phase Protein Microarrays -- Next-Generation Sequencing (NGS) -- Still a Struggle: Achieving Clinical Trial Status -- Commercial Biomarker Assays -- Quo Vadis, Biomarker Assays? -- References -- Clinical Validation / Mads Almose Røpke -- Introduction -- Classification of Biomarkers -- Translational Use of Biomarkers -- Biomarkers in Clinical Studies -- Healthy Volunteer Studies -- Early Patient Studies -- Confirmatory Clinical Studies -- Enrichment Design -- Biomarker-Stratified Design -- Safety Markers in Clinical Development -- Statistical Considerations -- Validation -- Regulatory Considerations for Implementation of Biomarkers in Clinical Studies -- Biorepositories and Ethics -- Conclusion -- References -- Genomics and Proteomics for Biomarker Validation / Paula Díez, Rosa M<sup>u</sup> Dégano, Nieves Ibarrola, Juan Casado, Manuel Fuentes -- Introduction -- Biomarker Discovery -- Challenges in Biomarker Discovery/Verification Phases -- Verification of Biomarkers -- Protein Binding Assays -- Targeted Proteomics -- Correlation Between MRM and ELISA -- MRM and Biomarker Pipeline -- Role of Biobanking in Biomarkers Validation -- Biobanking Challenges Associated with Biomarker Discovery and Validation -- Preanalytical Variations and Lack of SOPs -- Biological Diversities -- Disease Heterogeneity -- Technical Limitations -- Validation and Clinical Trials -- Lack of Stable Biorepository -- Conclusions -- References
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| Subject
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Biochemical markers.
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| Dewey Classification
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572.86
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| LC Classification
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QH438.4.B55
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| Added Entry
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Seitz, Harald
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Schumacher, Sarah
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Ohio Library and Information Network.
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