Research And Markets The Inability To Accurately Predict Toxicity Early In Drug Development Cost The Pharmaceutical Industry $8 Billion In 2003, Approximately One-Third The Cost Of All Drug Failures

Research and Markets (researchandmarkets.com/reports/c9045) has announced the addition of Toxicogenomics and Predictive Toxicology: Market and Business Outlook to their offering.

(PRWEB) November 18, 2004 -- Primarily, this is because safety problems are often detected late in the drug development pathway, after hundreds of millions of dollars have already been invested in potential therapeutics. Even when drugs successfully obtain FDA approval and reach the market, they remain vulnerable to costly safety issues. A recent example is Mercks withdrawal of the blockbuster drug Vioxx from the market due to safety concerns which caused the companys stock to plunge 25% in one day. Indeed, predictive toxicology and toxicogenomics technologies are of growing interest to government regulators, who have issued several reports recently calling for more predictive toxicology and toxicogenomics approaches to be used in assessing drug safety.

Research and Markets (http://www.researchandmarkets.com/reports/c9045) has announced the addition of Toxicogenomics and Predictive Toxicology: Market and Business Outlook to their offering.

Toxicogenomics and Predictive Toxicology: Market and Business Outlook addresses the significant need and potential for predictive toxicology in drug development. The report evaluates a number of novel approaches to toxicology research that have become available over the past five years that are raising optimism for dramatic improvements in the field. A detailed and insightful business outlook on the strategic, regulatory, and marketplace issues driving growth of toxicogenomic and predictive toxicology applications completes the analysis.

The ability to predict the toxic effects of potential new drugs is crucial to prioritizing compound pipelines and eliminating costly failures in drug development.

Toxicogenomics and Predictive Toxicology: Market and Business Outlook examines new predictive toxicology approaches including in vivo, in vitro, and in silico technologies such as toxicogenomics, metabolomics, new animal models, and computational methods. Predictive toxicology differs from traditional toxicology testing primarily by having a greater emphasis on low-cost, high through-put assays, anticipating toxic responses rather than measuring them after they occur; and by having a greater emphasis on understanding the underlying mechanisms of action rather than just monitoring toxic response.

Predictive toxicology is still in its early stages, characterized by the use of gene expression profiles to gain a basic understanding of whether a compound has a clean" or messy" profile. It is still some way off from replacing traditional toxicology testing. However, the tremendous advantages of these approaches, as well as pressure from the FDA to improve toxicology testing in drug development, indicate that advancements in predictive toxicology will play an increasing and accelerating role in drug development. This report is crucial reading for companies that are exploring the potential benefits of these methods and that wish to realize a maximum return on their R&D spending.

Predictive toxicology approaches are being explored at every step of the drug development safety evaluation pathway.

This report evaluates the following:
- In silico predictive methods.
- Genomic approaches (toxicogenomics) to obtain early markers of cell response.
- Proteomic assays (toxicoproteomics) to obtain biomarkers of toxicity in both preclinical and clinical phases of drug development.
- Novel approaches to in vitro assays, such as animal on a chip."
- Metabonomics/metabolomics technology.
- Pharmacogenomics.
- New animal models.

The contents of this report are as follows:
- Chapter 1. Introduction
- Chapter 2. The Role of Toxicology in Drug Development
- Chapter 3. Toxicogenomics
- Chapter 4. Technologies for Predictive Toxicology
- Chapter 5. Business and Strategic Issues

For more information visit http://www.researchandmarkets.com/reports/c9045

Laura Wood
Senior Manager
Research and Markets
press@researchandmarkets.com
Fax: +353 1 4100 980

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