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Abstract Metabolomics is a relatively new field of 'omics' technology that is primarily concerned with the global or system-wide characterization of small molecule metabolites using technologies such as nuclear magnetic resonance, liquid chromatography and/or mass spectrometry. Its unique focus on small molecules and the physiological effects of small molecules aligns the field of metabolomics very closely with the aims and interests of many researchers in the pharmaceutical industry. Because of its conceptual and technical overlap with many aspects of pharmaceutical research, metabolomics is now finding applications that span almost the full length of the drug discovery and development pipeline, from lead compound discovery to post-approval drug surveillance. This review explores some of the most interesting or significant applications of metabolomics as they relate to pharmaceutical research and development. Specific examples are given that show how metabolomics can be used to facilitate lead compound discovery, to improve biomarker identification (for monitoring disease status and drug efficacy) and to monitor drug metabolism and toxicity. Other applications are also discussed, including the use of metabolomics to facilitate clinical trial testing and to improve post-approval drug monitoring. These examples show that metabolomics potentially offer drug researchers and drug regulators an effective, inexpensive route to addressing many of the riskier or more expensive issues associated with the discovery, development and monitoring of drug products.
Over the past two decades the process of drug discovery and development has become increasingly more expensive, difficult and risky. The costs of bringing a new drug through all phases of testing and development has grown from $US230 million (in 1987) to more than $US800 million (in 2002) to an estimated $US1.2 billion today.[1] At the same time the number of new drug approvals is steadily declining.[2] This reflects the fact that the pharmaceutical industry is simply running out of diseases or disease targets that can be treated with 'simple' drugs (i.e. enzyme inhibitors). It also underscores the point that the diseases of interest today (cancer, heart disease, obesity, Alzheimer's disease) are complex disorders that do not present pharmaceutical researchers with simple or singular drug targets. Even if a promising lead compound is identified for one of today's 'priority' diseases, the odds that it will become a drug are very low. Only 1 in...