title: [Clinical drug research in children: current international guidelines. Committee for Proprietary Medicinal Products].
abstract: Drugs research in children entails a number of problems: medical-ethical, pharmacological (owing to the immaturity of the organs and the growth and development of the child) and financial (because children do not use many drugs). Consequently, children are exposed to insufficiently tested drugs and new therapeutic possibilities are withheld from them. Currently, little clinical drugs research in children is being carried out, but this is about to change. By now, European guidelines have been drawn up for the performance of clinical drugs trials according the 'good clinical practice' standards in children. In the Netherlands, a cooperative body has been set up (the Pediatric Pharmacology Network), which is to promote and coordinate paediatric pharmacological research in according with these guidelines.
authors.affiliation: Centre for Human Drug Research, Pediatric Pharmacology Network, Leiden.
authors.forename: I
authors.initials: I
authors.lastname: Ruys-Dudok van Heel
authors.forename: A F
authors.initials: AF
authors.lastname: Cohen
authors.forename: J M
authors.initials: JM
authors.lastname: Wit
authors.forename: A J
authors.initials: AJ
authors.lastname: van der Heijden
authors.forename: J N
authors.initials: JN
authors.lastname: van den Anker
authors.forename: A H
authors.initials: AH
authors.lastname: van Meurs
mesh_terms: D002648:Child; D002986:Clinical Trials as Topic; D004358:Drug Therapy; D004992:Ethics, Medical; D005060:Europe; D006801:Humans; D009426:Netherlands; D010599:Pharmacokinetics