Emerging Safety Science: Workshop Summary

by Robinson, Sally

• ISBN13: 9780309110129
• ISBN10: 0309110122
• Edition: 1st
• Format: Paperback
• Copyright: 2008-03-01
• Publisher: NATL ACADEMY OF SCIENCE

Table of Contents

Introduction	p. 1
Investigative Toxicology: The State of the Art	p. 5
Pulmonary Hemorrhage	p. 6
Bone Physeal Abnormalities	p. 7
Heart Valve Lesions	p. 10
Summary	p. 11
Screening Technologies I: Human Cell-Based Approaches	p. 13
The Ideal Screen	p. 13
The BioMAP System	p. 14
Contextual Drug Analysis	p. 22
Summary	p. 27
Screening Technologies II: Toxicogenomics	p. 28
Modernizing Predictive Toxicology	p. 28
Toxicogenomics at Iconix	p. 30
Toxicogenomics at Bristol-Myers Squibb	p. 35
Toxicogenomics at Abbott Laboratories	p. 41
Summary	p. 48
Screening Technologies III: Metabolomics	p. 50
Metabolomics at Metabolon	p. 51
Metabolomics at Biocrates	p. 55
Screening Technologies IV: Pharmacogenetics	p. 59
Abacavir and the Hypersensitivity Reaction	p. 59
The Abacavir Pharmacogenetics Program	p. 60
Implications for the Future	p. 64
Qualifying Biomarkers	p. 65
The Ideal Biomarker	p. 65
Qualification of Nephrotoxicity Biomarkers	p. 66
Summary	p. 73
Pharmacovigilance	p. 74
Pharmacovigilance at GlaxoSmithKline	p. 74
Statistical Issues in Analyzing Spontaneous Report Databases	p. 77
Active Surveillance for Anticipated Adverse Events	p. 84
Integration	p. 93
An Integration Tool at GlaxoSmithKline	p. 93
The Elsevier Database (PharmaPendium)	p. 96
An FDA Perspective	p. 99
The Future of Safety Science	p. 106
Prediction	p. 106
Surveillance	p. 108
Summary	p. 114
References	p. 115
Appendixes
Workshop Agenda	p. 117
Speaker Biographies	p. 125
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