Research studies to evaluate drugs in children is critical for determining the safety and efficacy of medications in children. Without this type of research, medication use in children will be limited to extrapolation from adult studies or off-label use for indications that have not been studied in children, thereby putting children at increased risk of adverse effects.
Growth and maturation can alter the kinetics, endorgan responses, and toxicities of drugs used in infants, children, and adolescents compared with adults. Furthermore, certain disorders affect children primarily, necessitating drug testing on appropriately aged subjects. It is morally imperative, therefore, to formally study drugs in children so that they can enjoy appropriate access to existing and new therapeutic agents. Read complete guidance here
