Clinical trials in pediatrics: The drug delivery dimension

Advanced Drug Delivery Reviews
Bankole Osuntokun

Abstract

The medical and drug delivery devices needs of children are quite different and unique when compared to that of adults. The practice of off label use and modification of adult devices for pediatric use is widespread. Attendant risk and adverse effects of such practices are poorly documented. Lack of pediatric age appropriate drug formulations constitutes a major impediment to pediatric drug labeling. While novel drug delivery system can help circumvent some of the pediatric formulations issues, the inherent high cost of development, the small size of the pediatric market, and the ethical dilemma of enrolling children in non-therapeutic clinical trials continue to militate against pediatric drug labeling as well medical devices development. Over the past four decades, major breakthroughs and achievements in basic biomedical science have supplied unprecedented potential information for improving human health. The need for properly designed and conducted pediatric clinical trials along with new drug delivery devices has never been greater. However major issues, like slow transition of promising basic scientific discovery into clinical applications, heavy regulatory burden, limited pediatric pharmacology research infrastructure, sp...Continue Reading

Citations

Feb 16, 2008·European Radiology·P Reimer, R Vosshenrich
Dec 23, 2006·Expert Opinion on Drug Delivery·Jörg Breitkreutz, Joachim Boos
Jan 20, 2012·Expert Opinion on Drug Delivery·Alejandro SosnikDiego A Chiappetta
May 21, 2013·Pharmacotherapy·Kristina BrooksKathleen A Stringer
Mar 31, 2016·BMC Medical Research Methodology·Delphine Meier-GirardCorinne Alberti
May 14, 2014·Advanced Drug Delivery Reviews·Alejandro Sosnik, Angel M Carcaboso
Jan 12, 2017·Paediatric Drugs·Gueorgui DubrocqB Ryan Phelps

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