Jan Trøst Jørgensen
Elsevier Science
e druk, 2019
9780128135396
Companion and Complementary Diagnostics
From Biomarker Discovery to Clinical Implementation
Specificaties
Paperback, blz.
|
Engels
Elsevier Science |
e druk, 2019
ISBN13: 9780128135396
Rubricering
Levertijd ongeveer 8 werkdagen
Samenvatting
Companion and Complementary Diagnostics: From Biomarker Discovery to Clinical Implementation provides readers with in-depth insights into the individual steps in the development of companion diagnostic assays, from the early biomarker discovery phase straight through to final regulatory approval. Further, the clinical implementation of companion diagnostic testing in the clinic is also discussed. As the development of predictive or selective biomarker assays linked to specific drugs is substantially increasing, this book offers comprehensive information on this quickly-evolving area of biomedicine. It is an essential resource for those in academic institutions, hospitals and pharma, and biotech and diagnostic commercial companies.
Specificaties
Inhoudsopgave
<p>1. Foreword<br>2. An Introduction to Companion and Complementary Diagnostics<br>3. The Drug-Diagnostic Co-Development Model<br>4. Systems Biology and Biomarker Development in Cancer Signaling Therapy<br>5. Immunohistochemistry<br>6. In Situ Hybridization<br>7. Polymerase Chain Reaction<br>8. Next Gen Sequencing Based Companion Diagnostics: From Biomarker Discovery to Clinical Implementation<br>9. Current Next Generation Sequencing Based Companion Diagnostics and their Analytical Validation<br>10. Companion and Complementary Diagnostics by Mass Spectrometry<br>11. Molecular Imaging Companion Diagnostics<br>12. Circulating Tumor DNA Analysis and Opportunities for Personalized Cancer Medicine<br>13. Companion Diagnostics Assay Development – Prototype, Verification and Analytical Validation<br>14. Tissue is the Issue: Challenges in Oncology Clinical Trial Tissue Sample Collection for Biomarker Analyses and Companion Diagnostics<br>15. Adaptive Trial Designs for Biomarker Driven Clinical Trials with Quantitative and Multiple Candidate Biomarkers<br>16. Companion Diagnostics Based on Time to Event Data<br>17. Regulatory Requirements for Companion Diagnostics and Drug-Diagnostic Co-Development in the United States of America<br>18. Companion Diagnostics and Biomarker Tests in the European Medicines Agency’s Assessment of Medicinal Products<br>19. Understanding the Current Regulatory Landscape for Companion Diagnostic Products in China<br>20. Regulatory requirements for companion diagnostics – Japan<br>21. Economic Evaluation of Companion and Complementary Diagnostics<br>22. A Risk Based Paradigm of Biomarkers in Clinical Trials<br>23. Implementing Companion Diagnostic Testing in the Clinic<br>24. Osimertinib (TAGRISSO) and the cobas EGFR Mutation Test v2<br>25. QMS Omecamtiv Mecarbil Immunoassay and Omecamtiv Mecarbil Co-Development<br>26. Current Status and Future Direction of Companion Diagnostics</p>