Pharmacokinetic Assessments – Mirvetuximab Soravtansine Sample Clauses

Pharmacokinetic Assessments – Mirvetuximab Soravtansine. The PK properties of MIRV and key metabolites will be evaluated following IV administration, as outlined in Table 2 and Table 8. Plasma samples will be collected to determine the concentration of MIRV (conjugate, total Ab, free DM4, S-methyl DM4 and possibly other metabolites). Blood samples for PK analysis will be taken at the following timepoints: they will sign the main study ICF and proceed with remaining screening procedures per the Schedule of Assessments. In some cases, the pre-screening ICF and main study ICF may be merged into a single ICF based on site-specific guidelines or preference.
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