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.
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References
Cella M, Knibbe C, Danhof M, Della Pasqua O (2010) What is the right dose for children? Br J Clin Pharmacol 70:597–603. doi:10.1111/j.1365-2125.2009.03591.x
DNDi (Drugs for Neglected Diseases Initiative) (2010) http://www.dndi.org. Accessed 14 Oct 2010
European Medicines Agency (2010) http://www.ema.europa.eu. Accessed 14 Oct 2010
FDA (Food and Drug Administration) (2010) http://www.fda.gov. Accessed 14 Oct 2010
FDAAA (FDA Amendment Acts) (2010) http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm. Accessed 14 Oct 2010
Gates Foundation (2010) http://www.gatesfoundation.org. Accessed 14 Oct 2010
Hilts PJ (2003) Protecting America’s health. Alfred A. Knopf, New York
ICH (2010) International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. http://www.ich.org. Accessed 14 Oct 2010
ICH E11 (2010) ICH tripartite guideline: clinical investigation of medicinal products in the pediatric population. http://www.ich.org/LOB/media/MEDIA487.pdf. Accessed 14 Oct 2010
MMV (Medicines for Malaria Venture) (2010) http://www.mmv.org. Accessed 14 Oct 2010
Rose K, van den Anker J (eds) (2010) Guide to paediatric drug development and clinical research. Karger, Basel, Switzerland, http://content.karger.com/ProdukteDB/produkte.asp?Aktion=showproducts&searchWhat=books&ProduktNr=253804. Accessed 14 Oct 2010. ISBN 978-3-8055-9362-5; e-ISBN: 978-3-8055-9363-2
Stoetter H (2007) Paediatric drug development: historical background of regulatory initiatives. In: Rose K, van den Anker JN (eds) Guide to paediatric clinical research. Karger, Basel, pp 25–32
Taussig HB (1962) A study of the German outbreak of phocomelia. JAMA 180(32):1106–1114
Wax P (1995) Elixirs, diluents, and the passage of the 1938 Federal Food, Drug and Cosmetic Act. Ann Intern Med 122:456–461
WHO (2010) http://www.who.int. Accessed 14 Oct 2010
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Rose, K., Pasqua, O.D. (2011). Development of Paediatric Medicines: Concepts and Principles. In: Seyberth, H., Rane, A., Schwab, M. (eds) Pediatric Clinical Pharmacology. Handbook of Experimental Pharmacology, vol 205. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-20195-0_5
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DOI: https://doi.org/10.1007/978-3-642-20195-0_5
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