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OBJECTIVE The purpose of this study was to test the hypothesis that the environment experienced by fetuses of mothers with gestational diabetes mellitus (GDM) and mothers with higher glucose concentrations that are in the normal range causes increased adiposity and altered glucose/insulin metabolism in childhood. RESEARCH DESIGN AND METHODS Children (n =(More)
AIMS In the EU, development of new medicines for children should follow a prospectively agreed paediatric investigation plan (PIP). Finding the right dose for children is crucial but challenging due to the variability of pharmacokinetics across age groups and the limited sample sizes available. We examined strategies adopted in PIPs to support paediatric(More)
Recent regulatory changes place greater emphasis on ensuring that new medicinal products are appropriately licensed for use in children. The EU Paediatric Regulation stipulates that development in this group should follow a prospectively agreed paediatric investigation plan (PIP) outlining all of the studies to be conducted. For any medicine, finding the(More)
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