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

被引：36

作者：

Turner, M. A. ^{[1
]}

Duncan, J. C. ^{[2
]}

Shah, U. ^{[2
]}

Metsvaht, T. ^{[3
]}

Varendi, H. ^{[4
]}

Nellis, G. ^{[4
]}

Lutsar, I. ^{[5
]}

Yakkundi, S. ^{[6
]}

McElnay, J. C. ^{[6
]}

Pandya, H. ^{[7
]}

Mulla, H. ^{[8
]}

Vaconsin, P. ^{[9
]}

Storme, T. ^{[9
]}

Rieutord, A. ^{[10
]}

Nunn, A. J. ^{[2
]}

机构：

[1] Univ Liverpool, Liverpool Womens NHS Fdn Trust, Dept Womens & Childrens Hlth, Inst Translat Med, Liverpool L8 7SS, Merseyside, England

[2] Alder Hey Childrens NHS Fdn Trust, Res & Dev, Liverpool L12 2AP, Merseyside, England

[3] Tartu Univ Clin, Dept Anesthesiol & Intens Care, EE-51014 Tartu, Estonia

[4] Tartu Univ Clin, Childrens Hosp, EE-51014 Tartu, Estonia

[5] Univ Tartu, Dept Med Microbiol, EE-50411 Tartu, Estonia

[6] Queens Univ Belfast, Sch Pharm, Clin & Practice Res Grp, Belfast, Antrim, North Ireland

[7] Univ Leicester, Dept Infect Immun & Inflammat, Leicester LE1 7RH, Leics, England

[8] Univ Hosp Leicester, Dept Pharm, Leicester, Leics, England

[9] Hosp Robert Debre, AP HP, Dept Pharm, Paris, France

[10] Hosp Antoine Beclere, AP HP, Dept Pharm, Clamart, France

来源：

ADVANCED DRUG DELIVERY REVIEWS | 2014年 / 73卷

基金：

英国医学研究理事会;

关键词：

Paediatrics; Neonates; Pharmaceutical development; Risk management; Risk analysis; Adverse effects; Medicines; Excipients; DEVELOPING MOUSE-BRAIN; INTENSIVE-CARE-UNIT; PROPYLENE-GLYCOL; POINT-PREVALENCE; CONTINUOUS-INFUSION; DRUG EXPOSURE; TERM INFANTS; PHARMACOKINETICS; LORAZEPAM; SURVEILLANCE;

D O I：

10.1016/j.addr.2013.11.003

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

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. (C) 2013 Elsevier B.V. All rights reserved.

引用

页码：89 / 101

页数：13

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