Julia Saperia

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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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