[Role of biomarkers in toxicity treatment "metabonomics" as a new biomarker discovery method].

For the treatment of clinical toxicity, investigations to determine the offending substance and rapid treatment are required. Particularly in the case of drug development, the side-effect biomarkers anticipated in a clinical study are based on various toxicological information gleaned from non-clinical studies. In fact, drug development may be discontinued if no biomarkers can be detected using conventional clinical laboratory methodology; therefore, new approaches for finding biomarkers are needed. The use of molecular toxicological methods using omics technology is expected to be an effective future approach. Metabonomics is the omics approach that inspects the movement of endogenous metabolites comprehensively and searches for a toxicological mechanism or biomarker. It is expected to become a useful biomarker discovery tool; in fact, reports about new biomarker discoveries made using metabonomics have already been published; however, the rate of metabolite identification and metabolism map development are not yet sufficient. Therefore, the development of a database containing this type of information as well as clinical information is necessary to be able to apply this technology to toxicological biomarker discovery. Further, studies for translation from the non-clinical to the clinical setting are very important for discovering useful metabonomic side-effect biomarkers. Therefore, building new collaborative relationships between pharmaceutical companies, doctors, medical technologists, and diagnostic agent companies is considered to be important.