Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Drug Toxicity: An Ongoing Challenge for Developers
- Drawbacks of Traditional Approaches to Toxicology
- Applications and Benefits of Biomarkers of Toxicity in Drug Development
- What Is a Biomarker?
- Why Use Biomarkers of Toxicity?
- Toxicogenomics: Technologies for Identifying Biomarkers of Toxicity
- Gene Expression Profiling
- Proteomics
- Metabolic Profiling
- Genotyping
- Examples of Potential Biomarkers of Toxicity
- α-Glutathion S-Transferase in Hepatotoxicity
- Kidney Injury Molecule-1 in Nephrotoxicity
- Troponins in Cardiotoxicity
- Inhibin B in Testicular Toxicity
- Challenges in Integrating Biomarkers of Toxicity into Drug Development
- Technical Issues
- Biomarker Validation
- Bioinformatics/Integration
- Intellectual Property
- The Critical Path Initiative and Biomarker Discovery
- Industry Trends
- Collaborative Agreements
- Aureus Pharma, ChemAxon, Sanofi-Aventis, and Budapest University of
Technology and Economics
- BG Medicine 17
- Ciphergen Biosystems
- Clinical Data
- Gene Logic
- Iconix Biosciences
- Metabometrix
- RxGen
- Consortia
- International Life Science Institute Health and Environmental Science
Institute
- Predictive Safety Testing Consortium
- Consortium for Metabonomic Toxicology
- Drug-Induced Liver Injury Network
- Outlook for Biomarkers of Toxicity
Tables
- 1. Select Drug Withdrawals Due to Safety Issues, 1997-2005
- 2. Metabolizing Enzymes Implicated in Drug-Induced Toxicity
- 3. Biomarker Classification
- 4. Profiled Companies Active in Development of Biomarkers of Toxicity
- 5. Profile of the Affymetrix/Iconix ToxFX Chip
Figures
- 1. Reasons for Termination of New Compounds
- 2. Applications and Benefits of Biomarkers of Toxicity in Drug Development
- 3. Schematic Example of Using DNA Microarray Technology in Biomarker
Discovery
- 4. 2DGE/MS-Based Protein Analysis Scheme in Biomarker Discovery
- 5. Framework for Data Integration from Different Technology Platforms
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