National Academy of Sciences | 150 Year Anniversary

Questions? Call 800-624-6242

| Items in cart [0]

The National Academies Press

PAPERBACK
price:$45.75
add to cart

Rights & Permissions

topleft topright

A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration (2011)
Board on Environmental Studies and Toxicology (BEST)

Citation Manager

. "Front Matter." A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration. Washington, DC: The National Academies Press, 2011.

Please select a format:

BibTeX EndNote RefMan


Page
XIV
bottomleft bottomright

The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy.


A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration

6-6

 

Distribution of number of hogs (left scale) and pounds of pork product (right scale) with various melamine tissue concentrations,

 

130

6-7

 

A decision tree for a testing-with-intervention decision involving infant formula and hog feed,

 

134

6-8

 

Potential outcomes of a decision to test infant formula but not animal feed, assuming a test without error, and interventions if the test result is positive,

 

135

6-9

 

Tree for the decision to test formula but not feed, including uncertainty about test accuracy,

 

136

TABLES

2-1

 

Summary of Attributes and Metrics,

 

33

3-1

 

Risk Attributes for Mitigation-Selection Decision for Biologics,

 

49

3-2

 

Estimated Numbers and Rates of Deaths and Illnesses from Rotavirus Disease in the Absence of Vaccination,

 

55

3-3

 

Example Calculation of Estimated Number of Deaths and Illnesses from Rotavirus Disease and RRV-TV-Induced Intussusceptions for Option to Leave the Vaccine on Market (Based on Median Estimates of all Factors),

 

59

4-1

 

Risk Attributes for Targeting Decision for Foods,

 

69

4-2

 

Agents Linked to Shrimp-Associated Outbreaks and Cases in the United States, 2001-2005,

 

79

5-1

 

Risk Attributes for Strategic-Investment Decision for Medical Devices,

 

96

5-2

 

Mortality Estimates,

 

99

6-1

 

Risk Attributes for Targeting Decision that Spans Food and Drug Administration Centers,

 

116

6-2

 

Formula Consumption by Age,

 

118

6-3

 

Estimated Dose for Infants Consuming Formula with Melamine at 100 ppm in Dry Formula,

 

120

6-4

 

Estimates of Mortality and Morbidity from Melamine Contamination in Infant Formula for the Hypothesized Dose-Response Relationship Incorporating Uncertainty in Exposure and Dose,

 

124

6-5

 

Concentration of Hog Production in 2006,

 

128

6-6

 

Melamine Doses to Humans Who Consume Pork with Various Melamine Tissue Concentrations,

 

131

Page
XIV