Biomarkers, Diagnostics and Precision Medicine in the Drug Industry
Critical Challenges, Limitations and Roadmaps for the Best Practices
- 294 pages
- English
- ePUB (mobile friendly)
- Available on iOS & Android
Biomarkers, Diagnostics and Precision Medicine in the Drug Industry
Critical Challenges, Limitations and Roadmaps for the Best Practices
About this book
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.- Provides the unique insight of an expert with extensive experience in diagnostics and clinical laboratory on one side and drug discovery and development on the other side- Addresses the challenges of drug development and precision medicine and suggests how to eliminate or mitigate these challenges through better utilization of biomarkers and diagnostics in drug development and patient management- Features case studies and real-life examples from different classes of biomarkers on different platforms for different therapeutic areas and includes more than 200 illustrations
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Information
Table of contents
- Cover image
- Title page
- Table of Contents
- Copyright
- Dedication
- Preface
- Chapter 1. Pharmaceutical crisis
- Chapter 2. Applications of biomarkers for different purposes in drug development
- Chapter 3. Pharmacogenetics of therapeutics
- Chapter 4. Precision medicine and companion diagnostics in drug development
- Chapter 5. Essential attributes of an acceptable in vitro diagnostic test
- Chapter 6. Fundamentals of assay development and validation
- Chapter 7. Essentials of laboratory quality management
- Chapter 8. Biological variables and their potential impact on biomarkers and precision medicine initiative
- Chapter 9. Preanalytical variables and their potential impact on biomarkers and precision medicine initiative
- Chapter 10. Analytical discrepancies and their potential impact on biomarkers and precision medicine initiative
- Chapter 11. Road map to best practices
- Index