Companion and complementary diagnostics : from biomarker discovery to clinical implementation /
Saved in:
| Other Authors: | |
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| Format: | Electronic eBook |
| Language: | English |
| Published: |
London, United Kingdom :
Academic Press, an imprint of Elsevier,
2019.
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| Subjects: | |
| Online Access: | CONNECT |
Table of Contents:
- Front Cover; Companion and Complementary Diagnostics; Copyright Page; Contents; List of Contributors; Foreword; 1 An Introduction to Companion and Complementary Diagnostics; 1.1 Introduction; 1.2 History; 1.3 Companion Diagnostics; 1.4 Complementary Diagnostics; 1.5 Concluding Remarks; References; 2 The Drug-Diagnostic Codevelopment Model; 2.1 Introduction; 2.2 Assay Development and Analytical Verification; 2.3 Cutoff Selection; 2.4 Analytical Validation; 2.5 Clinical Validation; 2.6 Clinical Trial Designs; 2.7 Regulatory Requirements; 2.7.1 United States
- 2.7.2 European Union and Other Countries2.8 The Impact of the Drug-Diagnostic Codevelopment Model; References; 3 Systems Biology in Biomarker Development for Cancer Signaling Therapy; 3.1 Introduction; 3.2 Systems Biomarker in Personalized Cancer Therapy; 3.3 Toward Systems Biomarker Development Through In Silico CDx Assay Model; 3.4 Systems Biomarker Identification in Signaling Control Interface; 3.5 Reprogramming of Signaling Networks as a Challenge in Systems Biomarker Identification in Cancer Therapy; 3.6 Systems Biomarker Identification by Exploring Contextual Genomic Features
- 3.7 Machine-Learning Approaches in Systems Genomics and Pharmacology: Biomarker Identification Based on Omics Data3.8 Conclusion; Acknowledgments; References; 4 Immunohistochemistry; Abbreviations; 4.1 Introduction; 4.2 General Principles of Immunohistochemistry Assay Development; 4.2.1 A Note About Preanalytical Procedures; 4.2.2 Antibody Production and Selection; 4.2.2.1 Production of Monoclonal Antibodies; 4.2.2.2 Production of Polyclonal Antibodies; 4.2.2.3 Comparative Advantages of Monoclonal and Polyclonal Antibodies; 4.2.2.4 Host Animal Effects
- 4.2.2.5 Professional Society Guidelines and Other Resources for Monoclonal Antibody Selection4.2.2.6 Primary Antibody Characterization; 4.2.3 Immunohistochemistry Assay Controls; 4.2.3.1 Tissue Controls; 4.2.3.2 Negative Reagent Controls; 4.2.4 Primary Antibody Titer; 4.2.5 Epitope Retrieval; 4.2.6 Detection Methods; 4.2.6.1 Detection Tags; 4.2.6.2 Direct and Indirect Detection; 4.2.6.3 Avidin-Biotin Detection Systems; 4.2.6.4 Streptavidin-Biotin Detection Systems; 4.2.6.5 Polymer- and Multimer-Based Detection Systems
- 4.2.7 Verification and Validation of Immunohistochemistry In Vitro Diagnostics4.2.8 Risk Classifications for Immunohistochemistry In Vitro Diagnostics; 4.2.8.1 Class I; 4.2.8.2 Class II; 4.2.8.3 Class III; 4.3 Considerations Specific to Complementary and Companion Diagnostic Immunohistochemistry Assays; 4.3.1 Components of Complementary and Companion Diagnostic Immunohistochemistry Assay Systems; 4.3.2 Complementary and Companion Diagnostic Assay Development Challenges and Constraints; 4.3.2.1 Scoring Algorithms; 4.3.2.2 Selection of Primary Antibody Titer
