Regulatory guidelines on metabolites in safety testing (MIST) were initially established in 2005 following intense discussions between industry and the US FDA. The guidelines were finalized in 2008, which has reignited the debate around how to apply these recommendations in today’s resource-constrained pharmaceutical environment.
The bioanalyst plays a major role in MIST, particularly with regards to defining the major human metabolites, establishing nonclinical safety coverage for important human metabolites, and the development and validation of appropriate bioanalytical methods to quantify metabolites.
This Special Focus Issue of teh peer-reviewed journal Bioanalysis includes a mixture of reviews, research articles and expert commentary focusing on the bioanalytical and regulatory advances and issues relating to metabolites in safety testing (MIST).
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