Table of Contents
Description of Chapters/Topics Covered
Chapter 1. Executive Overview of the Space
- Scope of this Report
- Market Definitions
- Market Segmentation
- Market Sizing
Chapter 2. Toxicity Screening in Drug Discovery: Current Trends and Emerging Themes in the Marketplace
- The Process of Drug Metabolism
- Various Biological Assay Systems for ADME and Toxicity Screening
- Bottom-up Market Survey of Worldwide Industry Participants: Qualitative
and Quantitative Market Analysis
Chapter 3. hERG, LQTS, Torsades de Pointes
- Drug-induced long QT syndrome (LQTS): Focus on hERG
- Why does hERG get blocked so easily?
- How widespread is hERG inhibition in the pharmaceutical industry
- Drug-acquired LQTS: Description of some high-profile drugs that affect hERG
- Analysis of the hERG marketplace
- Regulatory Section: ICH S7B and E14 guidelines
Chapter 4. Toxicity Screening Industry landscape: Perspectives from the Pharmaceutical Industry
- Genentech, Inc.
- Merck
- Abbott
- GlaxoSmithKline
- Eli-Lily & Co.
- AstraZeneca
- Celgene Corporation
- Bristol-Myers Squibb
Chapter 5. Developing Drugs with Safety Signals: Industry Perspectives
- University of Maryland
- Pfizer
- US FDA
Chapter 6. Toxicity Industry Landscape: perspectives from Regulatory Agencies
Appendix 1. Research Methodology
Appendix 2. hERG: Technology and Business
- Supporting Technical and Regulatory Trends Analysis
Appendix 3. Preclinical and Clinical non-QT Testing: Industry Perspectives
Appendix 4. Cardiotoxicity and Troponins: Industry Perspectives
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