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Biomarkers in Drug Development A Handbook of Practice Application and Strategy 1st Edition by Michael R Bleavins, Claudio Carini, Malle Jurima Romet, Ramin Rahbari ISBN 0470169273 978-0470169278

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Biomarkers in Drug Development A Handbook of Practice Application and Strategy Michael R. Bleavins Digital Instant Download

Author(s): Michael R. Bleavins, Claudio Carini, Mallé Jurima,Romet, Ramin Rahbari
ISBN(s): 9780470169278, 0470169273
Edition: Kindle
File Details: PDF, 5.67 MB
Year: 2010
Language: english
SKU: EB-1938470 Category: Tags: , , , ,

Biomarkers in Drug Development A Handbook of Practice Application and Strategy 1st Edition by Michael R. Bleavins, Claudio Carini, Mallé Jurima-Romet, Ramin Rahbari – Ebook PDF Instant Download/Delivery: 0470169273, 978-0470169278

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Product details:

ISBN 10: 0470169273 

ISBN 13: 978-0470169278

Author:  Michael R. Bleavins, Claudio Carini, Mallé Jurima-Romet, Ramin Rahbari 

Discover how biomarkers can boost the success rate of drug development efforts

As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine.

Biomarkers in Drug Development is divided into eight parts:

  • Part One offers an overview of biomarkers and their role in drug development.

  • Part Two highlights important technologies to help researchers identify new biomarkers.

  • Part Three examines the characterization and validation process for both drugs and diagnostics, and provides practical advice on appropriate statistical methods to ensure that biomarkers fulfill their intended purpose.

  • Parts Four through Six examine the application of biomarkers in discovery, preclinical safety assessment, clinical trials, and translational medicine.

  • Part Seven focuses on lessons learned and the practical aspects of implementing biomarkers in drug development programs.

  • Part Eight explores future trends and issues, including data integration, personalized medicine, and ethical concerns.

Each of the thirty-eight chapters was contributed by one or more leading experts, including scientists from biotechnology and pharmaceutical firms, academia, and the U.S. Food and Drug Administration. Their contributions offer pharmaceutical and clinical researchers the most up-to-date understanding of the strategies used for and applications of biomarkers in drug development.

Table of contents:

  1. Biomarkers and Their Role in Drug Development

  2. Biomarkers Are Not New

  3. Biomarkers: Facing the Challenges at the Crossroads of Research and Health Care

  4. Enabling Go/No Go Decisions

  5. Identifying New Biomarkers: Technology Approaches

  6. Imaging as a Localized Biomarker: Opportunities and Challenges

  7. Protein Biomarker Discovery Using Mass Spectrometry-Based Proteomics

  8. Quantitative Multiplexed Patterning of Immune-Related Biomarkers

  9. Gene Expression Profiles as Preclinical and Clinical Cancer Biomarkers of Prognosis, Drug Response, and Drug Toxicity

  10. Use of High-Throughput Proteomic Arrays for the Discovery of Disease-Associated Molecules

  11. Characterization and Validation

  12. Characterization and Validation Biomarkers in Drug Development: Regulatory Perspective

  13. Fit-for-Purpose Method Validation and Assays for Biomarker Characterization to Support Drug Development

  14. Molecular Biomarkers from a Diagnostic Perspective

  15. Strategies for the Co-Development of Drugs and Diagnostics: FDA Perspective on Diagnostics Regulation

  16. Importance of Statistics in the Qualification and Application of Biomarkers

  17. Biomarkers in Discovery and Preclinical Safety

  18. Qualification of Safety Biomarkers for Application to Early Drug Development

  19. Development of Serum Calcium and Phosphorus as Clinical Biomarkers for Drug-Induced Systemic Mineralization: Case Study with a MEK Inhibitor

  20. Biomarkers for the Immunogenicity of Therapeutic Proteins and Its Clinical Consequences

  21. New Markers of Kidney Injury

  22. Translating from Preclinical Results to Clinical and Back

  23. Translation Medicine – A Paradigm Shift in Modern Drug Discovery and Development: The Role of Biomarkers

  24. Clinical Validation and Biomarker Translation

  25. Predicting and Assessing an Inflammatory Disease and Its Complications: Example from Rheumatoid Arthritis

  26. Pharmacokinetic and Pharmacodynamic Biomarker Correlations

  27. Validating In Vitro Toxicity Biomarkers Against Clinical Endpoints

  28. Biomarkers in Clinical Trials

  29. Opportunities and Pitfalls Associated with Early Utilization of Biomarkers: Case Study in Anticoagulant Development

  30. Integrating Molecular Testing Into Clinical Applications

  31. Biomarkers for Lysosomal Storage Disorders

  32. Value Chain in the Development of Biomarkers for Disease Targets

  33. Lessons Learned: Practical Aspects of Biomarker Implementation

  34. Biomarkers in Pharmaceutical Development: The Essential Role of Project Management and Teamwork

  35. Integrating Academic Laboratories into Pharmaceutical Development

  36. Funding Biomarker Research and Development Through the Small Business Innovative Research Program

  37. Novel and Traditional Nonclinical Biomarker Utilization in the Estimation of Pharmaceutical Therapeutic Indices

  38. Anti-Unicorn Principle: Appropriate Biomarkers Don’t Need to Be Rare or Hard to Find

  39. Biomarker Patent Strategies: Opportunities and Risks

  40. Where Are We Heading and What Do We Really Need?

  41. IT Supporting Biomarker-Enabled Drug Development

  42. Redefining Disease and Pharmaceutical Targets Through Molecular Definitions and Personalized Medicine

  43. Ethics of Biomarkers: The Borders of Investigative Research, Informed Consent, and Patient Protection

  44. Pathodynamics: Improving Biomarker Selection by Getting More Information from Changes Over Time

  45. Optimizing the Use of Biomarkers for Drug Development: A Clinician’s Perspective

  46. Nanotechnology-Based Biomarker Detection

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Tags: Michael R Bleavins, Claudio Carini, Malle Jurima Romet, Ramin Rahbari, Biomarkers, Drug, Development, Handbook, Practice, Application, Strategy