Publications
New publication highlights the potential of model-informed approaches to support paediatric antibiotic development
A new publication partly funded by the ERAMET project highlights how modelling and simulation methodologies can support the advancement of paediatric medicine development. Published in the British Journal of Clinical Pharmacology, the study “Extrapolation and pharmacokinetic protocol design optimization for ceftriaxone as an exemplar for the development of antibiotics for children” explores how model-informed approaches can optimise pharmacokinetic study design and dose selection, using ceftriaxone as a reference case for the development of antibiotics in children.
Developing medicines for paediatric populations remains challenging, with clinical studies often facing limitations linked to small patient populations, limited data availability, and the need to design trials that are both scientifically robust and adapted to children’s specific needs. Through its focus on innovative methodologies, ERAMET aims to strengthen evidence generation and support more informed decision-making throughout the medicine development process.
The publication provides further insights into how quantitative approaches can strengthen paediatric drug development by supporting the design of more efficient clinical studies and guiding regulatory decision-making. By demonstrating the potential of these techniques in the development of paediatric antibiotics, the study aligns with ERAMET’s overall objective of improving research methodologies and supporting more effective medicine development for paediatric and rare disease populations.
Within this framework, ERAMET continues to foster collaboration between researchers, regulators, and stakeholders to promote the uptake of innovative tools that can ultimately contribute to the development of safer and more effective treatments for children.