Table of Contents

Approaches used by others and existing safety frameworks.
The framework.
Categories of scientific evidence--human information and data.
Categories of scientific evidence--animal data.
Categories of scientific evidence--information about related substances.
Categories of scientific evidence--in vitro data.
Interactions.
Vulnerable groups and prevalence of use.
Scientific principles for integrating and evaluating the available data.
Applying the framework: case studies using the prototype safety monographs.
Factors influencing use of the safety framework.
Findings and recommendations.