عنوان

Biomarker validation :

(Number (ISBN

3527337199

(Number (ISBN

3527680659

(Number (ISBN

3527680667

(Number (ISBN

3527680675 (Epub)

(Number (ISBN

3527680683 (mobi)

(Number (ISBN

9783527337194

(Number (ISBN

9783527680658

(Number (ISBN

9783527680665

(Number (ISBN

9783527680672 (Epub)

(Number (ISBN

9783527680689 (mobi)

Erroneous ISBN

9783527337194

Number

dltt

Title Proper

Biomarker validation :

General Material Designation

[Book]

Other Title Information

technological, clinical and commercial aspects /

First Statement of Responsibility

edited by Harald Seitz and Sarah Schumacher

Specific Material Designation and Extent of Item

1 online resource

Text of Note

Includes bibliographical references and index

Text of Note

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^u 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

0

International Standard Book Number

9783527680658

Biochemical markers.

SCI-- 007000

Number

Edition

Class number

Schumacher, Sarah

Seitz, Harald

Ohio Library and Information Network.

Date of Transaction

20160603081227.4

Cataloguing Rules (Descriptive Conventions))

pn

Electronic name

[Book]

Y