The majority of drugs used in the paediatric population are not tested for children. With most drugs having inadequate information about dosing regimen, dose adjustment and administration and safety in this group, the EU-funded GRiP initiative integrated global efforts towards standard practice.
Randomised controlled trials (RCTs) are considered the gold standard for assessing the efficacy of drugs prior to their approval for use in the general population. In children, physiological characteristics such as growth and hormonal status are different from adults and have impact on both pharmacokinetics and pharmacodynamics. Separate evaluation is required including adverse side effects for the different paediatric age groups, e.g. neonates.
Further information: Study and development of safe and effective medicines for children