Goals and General Strategies

One of major tasks of drug metabolism in drug development is to determine the exposure of drug metabolites in humans and toxicological species, especially the assessment of whether human circulating metabolites are present in the plasma of toxicology species at appropriate levels. The task usually is accomplished by qualitative and quantitative profiling in human and animal 

ADME studies with radiolabeled material. Comparative metabolie profiling data, especially metabolite profiles in plasma across species, have very important implications for drug development, including  

Finding a unique and/or major metabolite in human circulation late in drug development could slow down the drug development process. Therefore, the FDA has recommended the in vivo metabolic evaluation in humans be performed as early as feasible (FDA, 2005b). 

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