Remember to consider the safety of human metabolites!
29 January 2020
The regulatory guidelines recommend evaluating the safety of human metabolites, in addition to the parent drug. The human metabolites should be adequately expressed in the preclinical tox-species to be considered safety tested. Admescope supports the metabolites in safety testing (MIST) evaluation by offering a number of services through the drug development process, to gain confidence in understanding whether the drug metabolites can be considered safe or if there are potential MIST issues.
The MIST process is initiated by in vitro cross-species comparison of major metabolic pathways, followed by comparing in vivo metabolites in preclinical tox-species and human. The MIST analysis confirms if adequate exposures to human metabolites are observed in preclinical tox-species according to FDA and EMA/ICH guidelines. MIST analysis is recommended to be performed as soon as the repeated dose samples are available from both human and tox-species. Finally, the samples from radiolabelled human ADME study are investigated with regard to metabolite profiling and characterisation for the final evaluation, whether the human metabolites of concern can be considered as safety tested.
A number of new members joining the Admescope team!
Plenty of new team members have joined Admescope: Toni Karhu, Natalia Karataeva and Maija Alakarjula.
Toni Karhu has a PhD in Biochemistry and Natalia Karataeva holds a Master's degree in Chemistry. These two scientists will strengthen our laboratory team. Maija Alakarjula (M.Sc. in pharmacy) has started as a Business Development Scientist in our sales and marketing team. The new team members bring in both industrial and academic experience.
Welcome aboard Toni, Natalia and Maija!