Table of Contents
Nonclinical Studies Subcommittee Advisory Committee for Pharmaceutical Science Introduction & FDA Objectives Gaithersburg Hilton December 14, 1999
Nonclinical Studies Subcommittee
Scientific Advances & Opportunities
An example of accelerating scientific information and technology:
Toxicology in the last millennium
Toxicology in the last half century
Current “Biomarkers” of Systemic Toxicity
Current approach to safety evaluation
Some Opportunities for New/Improved Toxicological Practices
Molecular Evolution of Defense Systems
PPT Slide
Some Damage- or Agent-Inducible Genes
PPT Slide
PPT Slide
What do we need to know?
Application of Safety Biomarkers to Human Studies
Biochemical Markers of Pathology
PPT Slide
Better biomarkers of cell integrity and homeostasis
PPT Slide
Effect of Doxorubicin (DXR) on Serum Cardiac Troponin T (TnT)
Influence of the Severity of Doxorubicin Induced Cardiomyopathy of the Concentration of Serum Cardiac Troponin T (TnT)
How to focus resources among opportunities?
Potential collaborators
Objectives
History and Next Steps
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