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

Advanced Drug Delivery Reviews

Volumn 73, Issue , 2014, Pages 89-101

  Turner, M A ^a   Duncan, J C ^b   Shah, U ^b   Metsvaht, T ^c   Varendi, H ^c   Nellis, G ^c   Lutsar, I ^d   Yakkundi, S ^e   McElnay, J C ^e   Pandya, H ^f   Mulla, H ^g   Vaconsin, P ^h   Storme, T ^h   Rieutord, A ⁱ   Nunn, A J ^b  

^a UNIVERSITY OF LIVERPOOL   (United Kingdom)

^b ALDER HEY CHILDREN'S NHS FOUNDATION TRUST   (United Kingdom)

^c TARTU UNIVERSITY CLINICS   (Estonia)

^d UNIVERSITY OF TARTU   (Estonia)

^e QUEEN'S UNIVERSITY BELFAST   (United Kingdom)

^f UNIVERSITY OF LEICESTER   (United Kingdom)

^g UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST   (United Kingdom)

^h HÔPITAL ROBERT DEBRÉ   (France)

ⁱ HÔPITAL ANTOINE BÉCLÈRE   (France)

Author keywords

Adverse effects; Excipients; Medicines; Neonates; Paediatrics; Pharmaceutical development; Risk analysis; Risk management

Indexed keywords

MEDICINE; PRODUCT DEVELOPMENT; RISK ANALYSIS; RISK ASSESSMENT; RISK MANAGEMENT; LIFE CYCLE; PEDIATRICS;

ADVERSE EFFECT; EXCIPIENTS; NEONATES; PAEDIATRICS; PHARMACEUTICAL DEVELOPMENT;

PEDIATRICS; RISK ASSESSMENT;

4 HYDROXYBENZOIC ACID ESTER; EXCIPIENT; METABISULFATE SODIUM; POLYSORBATE 80; PROPYLENE GLYCOL; SULFATE; UNCLASSIFIED DRUG; ALCOHOL; ALPHA TOCOPHEROL; CORTICOSTEROID; DEXAMETHASONE; HYDROCORTISONE; METHYL PARABEN; PHENOBARBITAL; POLYSORBATE 20; PROPYL PARABEN; SODIUM METABISULFITE; SORBITOL;

CHEMICAL ANALYSIS; CONCENTRATION (PARAMETERS); DATA ANALYSIS; DECISION MAKING; DRUG FORMULATION; EXCIPIENT COMPATIBILITY; FOOD ANALYSIS; FOOD SAFETY; HAZARD ASSESSMENT; HUMAN; MATHEMATICAL COMPUTING; MATHEMATICAL MODEL; MEDICAL INFORMATION; NEWBORN; NONHUMAN; ORGANIZATIONAL DOWNSIZING; ORGANIZATIONAL EFFICIENCY; PRIORITY JOURNAL; PROCESS DEVELOPMENT; REVIEW; RISK ASSESSMENT; RISK FACTOR; RISK MANAGEMENT; SAMPLE SIZE; DRUG DEVELOPMENT; EXPOSURE; LIQUID CHROMATOGRAPHY; MEDICAL DECISION MAKING; NEWBORN PERIOD; PHARMACOEPIDEMIOLOGY; QUANTITATIVE ANALYSIS; SAFETY; TANDEM MASS SPECTROMETRY; TOXICITY TESTING; ANIMAL;

ANIMALS; EXCIPIENTS; FOOD SAFETY; HUMANS; INFANT, NEWBORN; RISK ASSESSMENT;

EID: 84902339878     PISSN: 0169409X     EISSN: 18728294     Source Type: Journal    
DOI: 10.1016/j.addr.2013.11.003     Document Type: Review

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