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Updated: Jun 8, 2026

Non-invasive Optical Measurement of Cerebral Metabolism and Hemodynamics in Infants
Published on: March 14, 2013
The need for noninvasive biomarkers for drug safety in neonatal circulation
1Department of Neonatology, Brighton & Sussex University Hospitals, Eastern Road, Brighton, BN2 5BE, UK. heike.rabe@bsuh.nhs.uk
Abstract:
The new EU Pediatric Drug Regulation covers the development of new drugs to include studies in children and newborn babies. An important part of the evaluation of a new drug will be data on efficacy and safety related to short-term and possible long-term effects. Owing to the special circumstances of studying drugs, especially in newborn babies, new, preferably noninvasive, biomarkers are required that can be used for assessment and monitoring in this vulnerable patient population. Feedback from expert groups and public stakeholders should be taken into account when introducing biomarkers into the study design. New noninvasive biomarkers for monitoring cardiovascular circulation in newborns will be used to illustrate an example of their practical use and implementation.
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