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EPTRI is a new enstablishing Research Infrastructure aiming to promote the paediatric research and provide optimal support to facilitate the accruing of knowledge in the many research fields necessary to guaranteeing the access to high quality and safe paediatric medicines
To increase knowledge on children growth and ontogeny characteristics relevant for the identification and development of novel therapies dedicated to children
To facilitate basic, preclinical, and translational research in paediatric medicines, providing access to key technologies, standardised models and analytical tools specific for children
General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry
The U.S. Food and Drug Administration (FDA) has recently published a guidance on neonatal clinical pharmacology studies. This guidance is intended...
Current State of Paediatric Reference Intervals and the Importance of Correctly Describing the Biochemistry of Child Development: A Review
Good paediatric biomarkers are critical for the decision-making process in child healthcare. However, reference intervals used in pediatric care...
EMA has recommended granting a conditional marketing authorization to the first gene therapy to treat Haemophilia A
The European Medicines Agency (EMA) has recommended granting a conditional marketing authorisation in the European Union (EU) for Roctavian...