[Therapeutics and clinical pharmacology of pediatric age].

Therapeutics and clinical pharmacology of pediatric age had a turbulent development ever since H. Shirkey spelled out his dramatic warning in 1968. that children are "therapeutic orphans". This warning was a message that in children drugs are used which are not scientifically studied in this population. With a few years of latency in which the ethical issues have been solved. Food and Drug Administration and other leading drug regulatory authorities requested that in the drug labeling a warning sentence should be included stating that since the drug was not studied in children, its use is not recommended. Thus, the children became therapeutic orphans for the second time. Today, the attitude is prevailing that is based on pharmacokinetic and safety data so that even before the formal studies have been completed for each age group, use of drugs in children should be allowed.