Over the past two decades considerable industry and regulatory discussion has focused around the importance of drug metabolites as potential sources of drug toxicity.
The issue of metabolite-mediated toxicity, and when it should be assessed, has become known as metabolites in safety testing (MIST). Essentially, it tackles the following question: When does a human metabolite become important? It is crucial to MIST to identify the major circulating human metabolites and ensure the species used in safety assessment are exposed to the same metabolites, at similar levels of exposure.
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