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

Abstract:

: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.

journal_name

Adv Drug Deliv Rev

authors

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

doi

10.1016/j.addr.2013.11.003

subject

Has Abstract

pub_date

2014-06-01 00:00:00

pages

89-101

eissn

0169-409X

issn

1872-8294

pii

S0169-409X(13)00262-7

journal_volume

73

pub_type

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