It is widely recognised by all stakeholders that the collection of data to support the effective and safe use of medicines in paediatric and poly-pharmacological patients (e.g. geriatric patients) poses feasibility and practical problems.
Traditional large-scale studies are not feasible as the standard for approving drugs in these specific populations. Extrapolation based on modelling and simulation is considered a potentially important approach to solve or contribute to this problem, but regulatory assessment guidelines have yet to be established.
The team in of Namur University and FAMHP are focused upon 4 following processes aiming at initializing a comprehensive understanding of the regulatory tasks related to Model informed drug development and assessment including models such as POPPK, PKPD, QSP, etc and organizing the data based upon key established principles into a practical baseline for further development within the project and in collaboration with ERAMET, a sister project focusing on development of an ecosystem for streamline assessment of modelling and simulation in paediatric and rare diseases in line with the ICH M15 guideline.
The focus at Namur University has been to initialize a comprehensive understanding of the task and organize the data based upon these principles into a practical baseline for further development of the project.
In recent progress we have:
- Organized the data into an interactive database questions/queries
- Generated the semantic knowledge from repository in the form of dynamic knowledge graph for medical data
- Automated the repository
- Ensured compatibility with EMA regulatory process.