This chapter contains sections titled:

• Introduction

• The Opportunity for Modernization Of Preclinical Safety Assessment

• A Decrease in the Efficiency of Development Of Pharmaceuticals

• The Critical Path Initiative

• The Critical Path Opportunities List

• Ideal Attributes of Safety Biomarkers

• Safety Biomarkers Improve Identification of the Best Candidate Therapeutics

• Safety Biomarkers Improve Identification of the Most Appropriate Subjects

• Safety Biomarkers Improve Identification of the Optimal Dose

• Safety Biomarkers can Assist in Identifying the Optimal Dose at a Specific Time

• Strategies for Identifying and developing Safety Biomarkers

• “Top-Down” Versus “Bottom-Up” Biomarker Identification Strategies

• Qualification of Safety Biomarkers

• A Safety Biomarker Qualification Process

• The Critical Path Institute and the Predictive Safety Testing Consortium

• Summary and Conclusions

• References