Biomarkers in drug discovery and development: a handbook of practice, application, and strategy Second Edition Bleavins

Biomarkers in drug discovery and development: a handbook of practice, application, and strategy – Ebook Instant Download/Delivery ISBN(s): 9781119187516,9781119187547,1119187516,1119187540,9781119187523, 1119187524

Product details:

• ISBN 10: 1119187524
• ISBN 13: 9781119187523
• Author:Ramin Rahbari; ‎Jonathan Van Niewaal; ‎Michael R. Bleavins
  

Table contents:

1 Biomarkers Are Not New

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

3 Enabling Go/No Go Decisions

4 Developing a Clinical Biomarker Method with External Resources: A Case Study

5 Imaging as a Localized Biomarker: Opportunities and Challenges

6 Imaging for Early Clinical Drug Development: Integrating Imaging Science with Drug Research

7 Circulating MicroRNAs as Biomarkers in Cardiovascular and Pulmonary Vascular Disease: Promises and Challenges

8 Characterization and Validation of Biomarkers in Drug Development: Regulatory Perspective

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

10 Applying Statistics Appropriately for Your Biomarker Application

11 Qualification of Safety Biomarkers for Application to Early Drug Development

12 A Pathologist’s View of Drug and Biomarker Development

13 Development of Serum Calcium and Phosphorus as Safety Biomarkers for Drug-Induced Systemic Mineralization: Case Study with the MEK Inhibitor PD0325901

14 New Markers of Kidney Injury

15 Biomarkers from Bench to Bedside and Back – Back-Translation of Clinical Studies to Preclinical Models

16 Translational Medicine – A Paradigm Shift in Modern Drug Discovery and Development: The Role of Biomarkers

17 Clinical Validation and Biomarker Translation

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

19 Validating In Vitro Toxicity Biomarkers Against Clinical Endpoints

20 Opportunities and Pitfalls Associated with Early Utilization of Biomarkers: A Case Study in Anticoagulant Development

21 Integrating Molecular Testing into Clinical Applications

22 IT Supporting Biomarker-Enabled Drug Development

23 Identifying Biomarker Profiles Through the Epidemiologic Analysis of Big Health Care Data – Implications for Clinical Management and Clinical Trial Design: A Case Study in Anemia of Chronic Kidney Disease

24 Computational Biology Approaches to Support Biomarker Discovery and Development

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

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

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

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

29 Translational Biomarker Imaging: Applications, Trends, and Successes Today and Tomorrow

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