5-1

Overview of the Metabolon process,

52

5-2

Global metabolomic analysis of commercially available HIV protease inhibitors,

54

6-1

Cumulative patient/years of exposure to abacavir products and spontaneous reports of HSR-associated mortality among those taking abacavir,

61

6-2

PREDICT-1 study design,

63

7-1

Serum creatinine as a biomarker for cisplatin-induced tubular necrosis/apoptosis,

68

7-2

Kim-1 as a biomarker for cisplatin-induced tubular necrosis/apoptosis,

69

7-3

ROC (receiver operating characteristic) analysis to compare biomarkers for cisplatin-induced tubular necrosis/apoptosis,

70

7-4

ROC (receiver operating characteristic) analysis to compare biomarkers for tubular necrosis mostly proximal (but sometimes not clearly localized) in 10 studies with different nephrotoxicants,

71

7-5

ROC (receiver operating characteristic) analysis to compare biomarkers for glomerular alteration/damage in 10 studies with different nephrotoxicants,

72

8-1

Disproportionality analysis calculation,

75

8-2

Heat map profiling of spontaneously reported adverse events for a single drug,

81

8-3

Association between torsades de pointes and the drugs cisapride and erythromycin, alone and in combination,

82

9-1

Example of hierarchical thesauruses for adverse events, drugs, and targets,

98

9-2

Drug development as an iterative process,

101

9-3

Illustration of a product development timeline that includes a monitored released phase,

104

10-1

Use of large health care databases to identify events of interest,

109