Abstract
This chapter aims to provide an overview of the regulatory guidance for the safety testing of drug metabolites issued by the US Food and Drug Administration (FDA) and the International Conference on Harmonization (ICH). These guidance documents refer to small molecule non-biologic drug products and outline the requirements for characterizing human circulating drug metabolites. Several aspects of the MIST guidance documents will be addressed, highlighting current MIST assessment strategies applied by the pharma industry and related technologies and methodologies which are typically employed.
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