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Preface | ||
Contributors | ||
1 | Biomarkers in Clinical Drug Development: Definitions and Disciplines | 1 |
2 | The Clinical Laboratory and Collection of Biomarker Data | 11 |
3 | Using Imaging Biomarkers to Demonstrate Efficacy in Clinical Trials: Trends and Challenges | 31 |
4 | Markers for Cardiac Repolarization and Risk Assessment | 73 |
5 | Development and Application of Interspecies Biomarkers in Nonclinical Safety Evaluations | 97 |
6 | Validation of Assays for the Bioanalysis of Novel Biomarkers: Practical Recommendations for Clinical Investigation of New Drug Entities | 119 |
7 | Validation of Biomarkers as Surrogates for Clinical Endpoints | 149 |
8 | Biomarkers for Pharmacokinetic/Pharmacodynamic Modeling and Clinical Trial Simulations | 169 |
9 | Pharmacogenomic Biomarkers | 189 |
10 | Quality Assurance and Regulatory Compliance | 211 |
11 | Biomarker Strategies in Drug Development: Striking a Balance Between Opportunities and Liabilities | 235 |
12 | Partnerships in Biomarker Research | 247 |
13 | Clinical Operations: Business Principles for Biomarker Applications | 271 |
Index | 281 |
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