Open AccessThe Revolution in Pediatric Drug Development and Drug Use: Therapeutic Orphans No More
Author(s) -
Gilbert J. Burckart,
Clara Kim
Publication year - 2020
Publication title -
the journal of pediatric pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.456
H-Index - 15
eISSN - 2331-348X
pISSN - 1551-6776
DOI - 10.5863/1551-6776-25.7.565
Subject(s) - medicine , drug , drug development , dosing , pharmacy , intensive care medicine , population , presentation (obstetrics) , pharmacology , pediatrics , family medicine , surgery , environmental health
This lecture was given by Dr. Burckart in association with presentation of the 2014 Sumner J. Yaffe Lifetime Achievement Award in Pediatric Pharmacology and Therapeutics, which is selected by the Pediatric Pharmacy Association. Multiple factors make conducting drug studies in the pediatric population difficult, resulting in a historic lack of information surrounding safe and efficacious drug dosing in children. The paradigm in pediatric drug development has shifted from normal science being that children are therapeutic orphans in the drug development system, to a model drift caused by pediatric legislation, to a model crisis caused by failed pediatric drug development trials, to finally a model revolution that includes pediatric patients routinely in drug development. Major regulatory actions and the accumulation of scientific evidence has created an environment where clinicians can expect properly labeled drug usage information for the pediatric population.