The high failure rate in the pharmaceutical industry has positioned biomarkers and personalized medicine in the frontline, as possible solutions. If executed right, biomarkers and companion diagnostics (CDx) can potentially help the drug industry enhance the probability of success, accelerate the time to market, and, more importantly, benefit patients by supporting accurate diagnosis and selection of the most effective and least toxic therapies. This book aims to examine the challenges and limitations in biomarkers and laboratory tests. It also offers advice on best practices to ensure proper application of biomarkers and bridges the gap between diagnostic business development claims and real-life deliverables. The book covers biomarkers for different purposes, provides examples from different technologies, which includes standard-of-care approved assays as well as for-investigational-use and for-research-use-only assays. It also includes new data for biomarkers in different therapeutic indications and offers case studies and practical examples.
This book serves as a reference to drug developers, IVD providers, clinical labs, healthcare givers, academicians, and researchers for best practices to help increase the probability of success in drug development and improve patient management.
1. Cover image - p. Cover 2. Title page - p. iii 3. Table of Contents - p. iii 4. Copyright - p. iv 5. Dedication - p. v 6. Preface - p. xi 7. Chapter 1. Pharmaceutical crisis - p. 1 8. Chapter 2. Applications of biomarkers for different purposes in drug development - p. 11 9. Chapter 3. Pharmacogenetics of therapeutics - p. 41 10. Chapter 4. Precision medicine and companion diagnostics in drug development - p. 75 11. Chapter 5. Essential attributes of an acceptable in vitro diagnostic test - p. 97 12. Chapter 6. Fundamentals of assay development and validation - p. 117 13. Chapter 7. Essentials of laboratory quality management - p. 149 14. Chapter 8. Biological variables and their potential impact on biomarkers and precision medicine initiative - p. 171 15. Chapter 9. Preanalytical variables and their potential impact on biomarkers and precision medicine initiative - p. 195 16. Chapter 10. Analytical discrepancies and their potential impact on biomarkers and precision medicine initiative - p. 215 17. Chapter 11. Road map to best practices - p. 241 18. Index - p. 275
The high failure rate in the pharmaceutical industry has positioned biomarkers and personalized medicine in the frontline, as possible solutions. If executed right, biomarkers and companion diagnostics (CDx) can potentially help the drug industry enhance the probability of success, accelerate the time to market, and, more importantly, benefit patients by supporting accurate diagnosis and selection of the most effective and least toxic therapies. This book aims to examine the challenges and limitations in biomarkers and laboratory tests. It also offers advice on best practices to ensure proper application of biomarkers and bridges the gap between diagnostic business development claims and real-life deliverables. The book covers biomarkers for different purposes, provides examples from different technologies, which includes standard-of-care approved assays as well as for-investigational-use and for-research-use-only assays. It also includes new data for biomarkers in different therapeutic indications and offers case studies and practical examples.
This book serves as a reference to drug developers, IVD providers, clinical labs, healthcare givers, academicians, and researchers for best practices to help increase the probability of success in drug development and improve patient management.
1. Cover image - p. Cover 2. Title page - p. iii 3. Table of Contents - p. iii 4. Copyright - p. iv 5. Dedication - p. v 6. Preface - p. xi 7. Chapter 1. Pharmaceutical crisis - p. 1 8. Chapter 2. Applications of biomarkers for different purposes in drug development - p. 11 9. Chapter 3. Pharmacogenetics of therapeutics - p. 41 10. Chapter 4. Precision medicine and companion diagnostics in drug development - p. 75 11. Chapter 5. Essential attributes of an acceptable in vitro diagnostic test - p. 97 12. Chapter 6. Fundamentals of assay development and validation - p. 117 13. Chapter 7. Essentials of laboratory quality management - p. 149 14. Chapter 8. Biological variables and their potential impact on biomarkers and precision medicine initiative - p. 171 15. Chapter 9. Preanalytical variables and their potential impact on biomarkers and precision medicine initiative - p. 195 16. Chapter 10. Analytical discrepancies and their potential impact on biomarkers and precision medicine initiative - p. 215 17. Chapter 11. Road map to best practices - p. 241 18. Index - p. 275
