Until recently, it was considered unethical or impossible to perform clinical trials of new
medicines in children. As a consequence, many medicines used for treating children are …

This review aims to give an updated overview of the worldwide situation of off-label and
unlicensed drug use in the paediatric field, also taking into account the safety of this kind of …

BACKGROUND: Off-label drug use in children is common and potentially harmful. In most
previous off-label use research, authors studied hospitalized children, specific drug classes …

Background and objective: Many drugs that are used to treat children are either not licensed
for use in paediatric patients (unlicensed) or prescribed outside the terms of the product …

Background In the past two decades, many legislative and regulatory initiatives were taken
globally to improve drug use in children. However, children are still found to be prescribed …

to the editor: The development of medications appropriately adapted for the health needs of
children should not be focused exclusively on national regulatory structures. Steinbrook …

Objectives. To determine the extent of unlicensed and off-label drugs prescribed in the level
3 neonatal intensive care unit (NICU) at the Royal Women's Hospital, Melbourne, Australia …

The pharmacokinetics and pharmacodynamics of drugs are different in adult and paediatric
populations, the latter being particularly heterogeneous. These differences in …

Background Population-based self-reported data on off-label medicine use independent
from health care provisions are lacking. The purpose of this study is to investigate off-label …

OBJECTIVES: Governmental agencies (US Food and Drug Administration and European
Medicines Agency) implemented initiatives to improve pediatric clinical research, starting in …