EMA Qualification Advice: Making the best use of the new nonclinical and in silico predictive tools generated in this WP3 to inform risk assessment on medication use during lactation (D3.11)

Le résumé fourni par la source

This deliverable summarizes the key aspects to consider when utilizing the non-clinical and in silico predictive tools developed in Work Package 3 (WP3) of the IMI ConcePTION project. WP3 focused on establishing a platform to predict drug transfer into human milk and consequent infant exposure, utilizing in vitro, in vivo, and in silico methodologies. The deliverable builds on insights from previous work (summarised in D3.10 and other deliverables), and addresses feedback from the European Medicines Agency (EMA), offering recommendations for integrating these tools into regulatory frameworks and clinical practice. While further refinement and ultimately formal validation of the development tools is required, these methodologies carry the promise to thoroughly address uncertainties regarding maternal medication safety for infants when mothers are breastfeeding. This document aims to guide stakeholders in leveraging the tools for improved medication safety assessments during lactation.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.