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



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