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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