Date:11/19/2012

427.3.1 Variability 427.3.2 Validity 437.3.3 Measurement Errors 437.4 Biomarker Classification 447.4.1 Biomarker Categories 457.4.2 Types of Biomarkers 457.4.3 Reasons for Surrogate Endpoint 'Failure' 478 Biomarkers in Drug Discovery - Integration of Biomarkers in Different Phases of Drug Development 498.1 Discovery 508.1.1 Predictive Safety Biomarkers 508.1.2 Mechanism of Action Markers 508.2 Preclinical Development 508.2.1 Prognostic and Epidemiological Biomarkers 508.2.2 Diagnostic Biomarkers 518.3 Clinical Development 528.3.1 Disease Progression Markers or Response to Therapy Markers 528.3.2 Surrogate Biomarkers 529 Biomarkers in Drug Discovery - Case Study 539.1 Role of HER2 Gene in Herceptin Development for Breast Cancer 539.1.1 Activation of Antibody-Dependent Cellular Cytotoxicity 539.1.2 Prevention of the Formation of p95HER2 539.1.3 Inhibition of HER2-activated Cell Proliferation 549.1.4 Inhibition of HER2-regulated Angiogenesis 549.1.5 Herceptin Side Effects 559.2 Role of BCR-ABL Fusion Protein in Development of Gleevec for Chronic Myelogenous Leukemia 5710 Biomarkers in Drug Discovery - Regulatory Trends 5910.1 Regulatory Landscape 5910.1.1 Investigative/Exploratory Biomarker 5910.1.2 Probable Valid Biomarker 5910.1.3 Known Valid Biomarker 5910.1.4 Letter Of Intent to Propose Biomarker Qualification 5910.1.5 Structure of Biomarker Qualification Briefing Document 6010.2 Validated Biomarker 6210.3 Regulatory Acceptance of Valid Biomarkers 6510.4 Regulatory Guidance from the FDA, EMA and MHLW 6511 Biomarkers in Drug Discovery - Promising Biomarkers 6611.1 Biomarkers for Alzheimer's Disease 6611.1.1 Imaging Biomarkers 6611.1.2 Fluid Biomarkers 6711.2 Biomarkers for Cancer 6711.2.1 Insulin-like Growth Factor 1 and 2 6911.2.2 OVA1 6911.2.3 Risk of Ovarian Malignancy Algorithm 6911.2.4 Serum Markers 6911.3 Biomarkers for Multiple Sclerosis 7011.3.1 Serum Marker: Brain-Derived Neurotrophic Factor 7011.3.2 Cerebrospinal Fluid Markers 7011.3.3 Imaging Marker 7111.
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