TY - CHAP
T1 - Safety assessment in pediatric studies
AU - Koren, Gideon
AU - Elzagallaai, Abdelbasset
AU - Etwel, Fatma
PY - 2011
Y1 - 2011
N2 - It typically takes many years before an association of a drug with a rare, serious adverse reaction is established. As related to pediatric drug use, evidence is even more erratic, as most drugs are used off labels. To enhance child safety, there is an urgent need to develop robust and rapid methods to identify such associations in as timely a manner as possible. In this chapter, several novel methods, both clinically based pharmacoepidemiological approaches and laboratory-based methods, are described.
AB - It typically takes many years before an association of a drug with a rare, serious adverse reaction is established. As related to pediatric drug use, evidence is even more erratic, as most drugs are used off labels. To enhance child safety, there is an urgent need to develop robust and rapid methods to identify such associations in as timely a manner as possible. In this chapter, several novel methods, both clinically based pharmacoepidemiological approaches and laboratory-based methods, are described.
KW - Adverse drug reactions
KW - Children
KW - Neonates
KW - Side effects
UR - http://www.scopus.com/inward/record.url?scp=80054933860&partnerID=8YFLogxK
U2 - 10.1007/978-3-642-20195-0_8
DO - 10.1007/978-3-642-20195-0_8
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C2 - 21882111
AN - SCOPUS:80054933860
SN - 9783642201943
T3 - Handbook of Experimental Pharmacology
SP - 169
EP - 180
BT - Pediatric Clinical Pharmacology
A2 - Seyberth, Hannsjorg
A2 - Seyberth, Hannsjorg
A2 - Schwab, Matthias
A2 - Schwab, Matthias
A2 - Rane, Anders
ER -