Safety assessment in pediatric studies

Gideon Koren, Abdelbasset Elzagallaai, Fatma Etwel

Research output: Chapter in Book/Report/Conference proceedingChapterpeer-review


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.

Original languageEnglish
Title of host publicationPediatric Clinical Pharmacology
EditorsHannsjorg Seyberth, Hannsjorg Seyberth, Matthias Schwab, Matthias Schwab, Anders Rane
Number of pages12
StatePublished - 2011
Externally publishedYes

Publication series

NameHandbook of Experimental Pharmacology
ISSN (Print)0171-2004
ISSN (Electronic)1865-0325


  • Adverse drug reactions
  • Children
  • Neonates
  • Side effects


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