ABSTRACT
High-throughput screening efforts in early drug discovery, combined with combinatorial and computational chemistry produce ever-increasing numbers of potential leads for
further testing. On the other end of the spectrum in drug development, increased regulatory hurdles and complex clinical programs have significantly raised the cost of drug development. Drugs withdrawn from the market due to safety issues have also highlighted the need for better safety testing prior to marketing new drugs. This presents a unique challenge to the pharmaceutical and biotechnology industries to reduce attrition by bringing forward safe and efficacious drugs with greater survival rates. A significant bottleneck in the drug discovery and development process is the nonclinical efficacy and safety evaluation, in particular the conduct of in vivo studies. While genomic and proteomic technology will play a part in alleviating this bottleneck in the future, they are not well positioned to assess in vivo toxicity of new chemical entities. Which tissue do you profile? When?What dose? Not to mention the low-throughput nature of these technologies. Metabonomic technology can help bridge this gap by providing a more rapid throughput method to identify target organ effects, as well as dose and time relationships early within a drug discovery program.
