title: Development of paediatric medicines: concepts and principles.
abstract: The term "off-label use of drugs in children" is common to current medical practice. A look into the historical context helps to elucidate the framework for the use of medicines in children. Proper drug labels are relatively new in history. They emerged half a century ago when U.S. legislation forced manufacturers to prove the safety and efficacy of drugs by adequate clinical trials. Today pharmaceutical progress is so obvious and well established that the discrepancy between its benefit for adults as compared to children started to be perceived by champions in different institutions. There is an increased understanding of the child's physiology during developmental growth, of the maturation of enzyme systems, of the pharmacokinetics and pharmacodynamics and of the differences in disease processes. The involved institutions include legislators, government, regulatory authorities, academic scientists, pharmaceutical companies, the WHO, to name just the most prominent ones, but there are many more. Driving forces for the improvement of medicines for children include societal priorities, the involvement of science, the mission of regulatory authorities the role of clinical pharmacologists, paediatricians, and the characteristics of our market-driven economy with its chaotic, contradictory and lively elements. We do not live in an ideal world, but there is progress, and children are likely to benefit from it.
authors: klausrose Consulting, Pediatric Drug Development & More, Birsstrasse 16, 4052 Basel, Switzerland. rose@granzer.biz
authors: Klaus
authors: K
authors: Rose
authors: Oscar
authors: O
authors: Della Pasqua
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics / Q000331:legislation & jurisprudence / Q000592:standards / Q000639:trends; D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence; D004341:Drug Evaluation / Q000191:economics / Q000331:legislation & jurisprudence / Q000592:standards / Q000639:trends*; D005060:Europe; D006291:Health Policy / Q000331:legislation & jurisprudence; D006803:Human Development / Q000502:physiology; D006801:Humans; D056687:Off-Label Use / Q000331:legislation & jurisprudence; D010330:Patents as Topic / Q000331:legislation & jurisprudence; D010372:Pediatrics / Q000331:legislation & jurisprudence / Q000592:standards / Q000639:trends*; D000069437:Pharmacological Phenomena / Q000502:physiology; D011446:Prospective Studies; D012189:Retrospective Studies; D014481:United States