Risk assessment of neonatal excipient exposure: Lessons from food safety and other areas

M A Turner, J C Duncan, U Shah, T Metsvaht, H Varendi, G Nellis, I Lutsar, S Yakkundi, J C McElnay, H Pandya, H Mulla, P Vaconsin, T Storme, A Rieutord, A J Nunn

Research output: Contribution to journalArticlepeer-review

41 Citations (Scopus)


Newborn babies can require significant amounts of medication containing excipients intended to improve the drug formulation. Most medicines given to neonates have been developed for adults or older children and contain excipients thought to be safe in these age groups. Many excipients have been used widely in neonates without obvious adverse effects. Some excipients may be toxic in high amounts in which case they need careful risk assessment. Alternatively, it is conceivable that ill-founded fears about excipients mean that potentially useful medicines are not made available to newborn babies. Choices about excipient exposure can occur at several stages throughout the lifecycle of a medicine, from product development through to clinical use. Making these choices requires a scalable approach to analysing the overall risk. In this contribution we examine these issues.
Original languageEnglish
Pages (from-to) 89–101
Number of pages13
JournalAdvanced Drug Delivery Reviews
Early online date13 Nov 2013
Publication statusPublished - 30 Jun 2014

Bibliographical note

Copyright © 2013 Elsevier B.V. All rights reserved.

ASJC Scopus subject areas

  • Pharmaceutical Science


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