Presenting recent applications in clinical development, pharmacokinetic/ pharmacodynamic modeling, and clinical trial simulation, this in-depth reference studies the role of biomarkers in successful drug formulation and development—utilizing the latest discoveries in biomarker science to determine the safety and efficacy of emerging drug compounds.

Contents

1. Biomarkers in clinical Drug Development: Definitions and Disciplines
2. The Clinical Laboratory and Collection of Biomarker Data
3. Using Imaging Biomarkers to Demonstrate Efficacy in Clinical Trials: trends and Challenges
4. Markers for Cardiac Repolarization and Risk Assessment
5. Development and Application of Interspecies Biomarkers in Nonclinical Safety Evaluations
6. Validation of Assays for the Bioanalysis of Novel Biomarkers: Practical Recommendations for Clinical Investigation of New Drug Entities
7. Validation of Biomarkers as Surrogates for Clinical Endpoints
8. Biomarkers in Pharmacokinetic/Pharmacodynamic Modeling and Clinical Trial Simulation
9. Pharmacogenomic Biomarkers
10. Quality Assurace and Regulatory Compliance
11. Biomarkers Strategies in Drug Development: Striking a Balance Between Opportunities and Liabilities
12. Partnerships on Biomarker Research
13. Clinical Operations: Business Principles for Biomarker Applications

Index

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