Practical and operational considerations related to pediatric oral drug formulation: An industry survey

Quotient Sciences, in collaboration with KU Leuven and academic partners, contributed to a comprehensive industry survey published in the International Journal of Pharmaceutics, examining current practices in pediatric oral drug product development. 

The study assessed how EU and US pediatric drug product development regulations have influenced formulation strategies, with a focus on the integration of in vitro, in silico, and clinical tools.

Findings revealed that while regulatory frameworks have driven progress, challenges remain in developing age-appropriate formulations, particularly for neonates and infants. The survey highlighted variability in the application of physiologically based pharmacokinetic (PBPK) modeling, biopharmaceutics, and predictive dissolution testing, underscoring the need for harmonized methodologies and improved data sharing across the industry.

This research supports the advancement of pediatric drug development by identifying key gaps and promoting the use of model-informed drug development (MIDD) approaches to optimize formulation design and regulatory alignment.

Download the resource to read more about the program.