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Keywords:

  • children;
  • clinical trials;
  • medication;
  • off-label prescribing

Abstract:  Knowledge of drug administration in children and infants has significantly lagged behind that of adults. Despite several paediatric therapeutic mishaps that have been a catalyst for major regulatory reform, the majority of registered medicines do not have indications or dosing for children. This paper will briefly summarise key issues in paediatric pharmacology, including differences in prescribing for children, off-label and unlicensed prescribing and conduct of paediatric clinical trials. A particular emphasis will placed on the situation in Australia.