Drug development
Metabolomics plays a key role in drug development, making an impact at several points in the drug-development process. However, metabolomics is not only a tool in the drug development process but bridge the gaps between preclinical and clinical, and clinical and market.
Metabolomics is involved in:
• Target identification and lead discovery and optimization.
• Preclinical efficacy assessment.
• Safety assessment: determination of characteristic metabolic biomarkers of physiological stress, tissue damage, general toxicity or organ-specific toxicity such as hepato and nephrotoxicity , being specially interesting those biomarkers associated with early exposure toxicity.
• Xenobiotic metabolism and xenobiotic-induced toxicity through reactive metabolites: the identification of reactive metabolites during the early stages of drug development helps to minimize its formation by optimizing the structure of the parent drug.
• Dose response: Dose response studies are crucial to determining safety levels and dosages for drugs: Metabolic profiling delivers the tools to determinates the physiological changes in real-time and monitor the consequences of changed drug dosages.
• Patient selection: as drugs effects and interaction amongst individuals can be highly variable, the identification of patient populations that are most likely to benefit from it or suffer an adverse effect is essential for success in the drug development and in the marketplace.