The key objective of the SAFE-PEDRUG project is to redefine and implement the strategy for pediatric drug research. Drug research in children is traditionally performed using a approach in which data of adult drug studies are extrapolated to children. History has shown that pharmacokinetics and pharmacodynamics in children can differ when compared to adults, as both pharmacokinetics and pharmacodynamics of drugs are different in children.

The majority or drugs currently administrated to children have not been tested in pediatric studies and are therefore used ‘off-label.’ This practice is undesirable and unethical since it exposes children to the risk of inadequate doses and side-effects. The European Regulatory Authorities have stated in the ‘Paediatric Regulation’ that drugs should also be evaluated in children.

We will develop a strategy for pediatric drug research that starts with the identification of shortcomings and needs in current knowledge and performs safe and ethical drug studies in all childhood developmental stages. The multidisciplinary consortium of this project consists of basic scientists , pharmacists, ethicists and pediatric subspecialities , This collaboration guarantees efficient drug research of children in all developmental stages. The SAFE-PEDRUG Advisory Board and Stakeholders Group surveys our research progress and quality.

To be concrete, following goals have been formulated:

• Identification of gaps in our current knowledge on safe and effective drug prescription in children.
• Development of a strategy that might prevent off-label drug use in children.
• Identification of adequate ‘surrogate parameters’ in pediatric drug research.
• Evaluation of the porcine juvenile animal model
• Refining physiology-based pharmacokinetic modeling for pediatric purposes
• Linkage of the above-mentioned modeling results to data from human trials.
• Study of pharmacokinetic and pharmacodynamics mechanisms in critically ill children and children with comorbidity, as well as (premature) neonates as these children need specific dose regimens and indications.
• Evaluation and refinement of ethical standards in paediatric drug research.