metabolites IN safety TESTING: SOLUTIONS TO MEET THE MIST REQUIREMENTS
An educational webinar on MIST strategy
The MIST strategy is a hot topic of the drug development process and is nowadays strongly recommended by the regulatory agency to ensure that the safety of metabolites found in humans is evaluated adequately in toxicological studies.
The regulatory agencies encourage an early understanding of the human metabolism, recommending that human circulating metabolites above a defined threshold are also observed in preclinical species at equal or greater levels than in human. The main challenge is how to balance this recommendation with the need to appropriately invest resources according to the stage of drug development. A suggested option is to adopt “alternative approaches”, early in the drug development process, able to generate reliable data for enabling prompt and informed decisions.
In this webinar, Ellenia Bordini, Research Expert, ADMET Preclinical Development, will cover various “alternative approaches” for an early evaluation of the major human circulating metabolites and for the assessment of their toxicological cover in preclinical species, in the absence of synthetic metabolite reference standards before performing a Human Radiolabelled Study.
About the speaker
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Ellenia is a Senior Scientist with over 20 years' experience in the pharmaceutical industry and has strong experience in pre-clinical drug development from candidate selection up to late clinical phase. Ellenia has extensive knowledge and background in the structural elucidation of metabolites in several biological matrices, generated from in vitro and/or in vivo studies conducted with or without radio-labelled drugs, by using liquid chromatography coupled with high resolution mass spectrometry. She is accountable for the scientific overview of the metabolite elucidation with special focus on safety testing strategy to evaluate human metabolism during clinical trials. Stream the webinar |
