Perspectives on Biomarker and Surrogate Endpoint Evaluation: Disscussion Forum Summary,9780309163248

Perspectives on Biomarker and Surrogate Endpoint Evaluation: Disscussion Forum Summary

by
Edition: 1st
ISBN13: 9780309163248
ISBN10: 0309163242
Format: Paperback
Pub. Date: 2011-01-01
Publisher(s): NATL ACADEMY OF SCIENCE
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Summary

Summary of a discussion forum that took place in Washington, DC on June 21-22, 2010.

Table of Contents

Introductionp. 1
Committee Findings and Recommendationsp. 3
Charge to the Committeep. 3
Definitionsp. 5
Recommendationsp. 7
FDA Perspectivesp. 29
Presentationp. 31
Presentationp. 33
Presentationp. 34
Presentationp. 37
Presentationp. 39
National Institutes of Health Perspectivesp. 43
Presentationp. 44
Presentationp. 48
Industry Perspectivesp. 51
Presentationp. 55
Presentationp. 56
Presentationp. 58
Presentationp. 59
Presentationp. 63
Presentationp. 64
Presentationp. 65
Public Health, Consumer, and Consulting Organization Perspectivesp. 69
Presentationp. 69
Presentationp. 71
Presentationp. 72
Presentation Thomas Fleming: Biomarkers and Surrogate Endpoints in Chronic Diseasep. 75
A Correlate Does Not a Surrogate Makep. 75
Validating Surrogate Endpointsp. 80
A Biomarker Hierarchyp. 83
Concluding Thoughtsp. 85
Key Themes, Challenges, and Opportunitiesp. 87
Biomarker Evaluation Frameworkp. 87
The Value of Biomarkers and Surrogate Endpointsp. 90
Considerations for Food and Nutrition Applicationsp. 91
Improving Communication and Understandingp. 93
Importance of the Biomarker Discussion Forump. 97
Referencesp. 99
Acronymsp. 103
Glossaryp. 107
Appendixes
Discussion Forum Agendap. 113
Summary from the Committee's Reportp. 115
Table of Contents provided by Ingram. All Rights Reserved.

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