ESNEE project aimed to provide an integrated assessment of exposure among neonates in Europe to potentially toxic excipients.
Main objectives:
- to undertake a comprehensive European questionnaire and point prevalence study of excipient exposure in neonates;
- to conduct a systematic review
- to develop EK models for selected excipients Observational case-controlled study.
Primary outcome measures:
To develop pilot excipient kinetic models to indicate how much of each selected excipient is in the bloodstream of babies who have been given medicines containing those excipients.