3-4

 

Examples of Standards and Guidelines for the Development and Use of Biomarkers,

 

86

3-5

 

Estrogen Receptor—The Classic Cancer Biomarker,

 

96

3-6

 

Herceptin/HercepTest Development and Approval,

 

98

3-7

 

EGFR Inhibitors—The Quest for Targeting Biomarkers,

 

102

4-1

 

Assessing the Value of OncotypeDX and MammaPrint,

 

118

FIGURE

2-1

 

EDRN informatics infrastructure,

 

44

TABLES

1-1

 

Use of Cancer Biomarkers in Patient Care,

 

23

1-2

 

Use of Biomarkers in Drug Development,

 

24

2-1

 

Examples of Biomarker Categories and High-Throughput Methods of Discovery,

 

30

2-2

 

Biomarker Validation and Qualification Requires Demonstration of Fitness for a Specified Purpose,

 

32



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