Pediatric Drug Studies Required by Law

JAMA ◽  
2004 ◽  
Vol 291 (4) ◽  
pp. 412 ◽  
Keyword(s):  
PEDIATRICS ◽  
1974 ◽  
Vol 54 (6) ◽  
pp. 670-672
Author(s):  
Alan K. Done

Clinicians may, at first glance, wonder why the paper in this issue by Levy and Yaffe1 on the volume of distribution of salicylate in children should concern them or, indeed, why it even appears in their journal. This important and excellent study is a prime example of the growing influence and involvement of clinical pharmacology and pharmacokinetics in medicine generally and pediatrics particularly. Already substantial, with the growing complexity of pediatric therapeutics, this relationship stands to become even more widespread and intense as a result of increasing emphasis on more and better pediatric drug studies. Evolving ethical-legal constraints notwithstanding,2 these must and will expand.


2020 ◽  
Vol 25 (7) ◽  
pp. 565-573
Author(s):  
Gilbert J. Burckart ◽  
Clara Kim

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.


2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
Vijay N. Yewale ◽  
Dhanya Dharmapalan

Promotion of appropriate and safe drugs in children is the need of the hour globally. Pediatric population by itself is a spectrum of different physiologies with significant variation in pharmacodynamics and pharmacokinetics. Unfortunately, 50–90% of drugs used in children today have never been actually studied in this population, and the results of drug studies done in adults are often extrapolated for use in children. Many medicines in pediatrics are off label or unlicensed. There is a spurt in drug resistance due to the overzealous prescription of antimicrobials not indicated, such as, using inadequate dosage or duration of drug regime leading to partially treated infections, using the wrong antimicrobial due to ignorance of causative organism, and finally using indigenous, irrational combinations. Availability of properly labeled and safe pediatric formulations, regular audit by pharmacists, judicious prescriptions, proper counseling about drug administration, surveillance of adverse effects, and pediatric drug trials can be the best possible interventions to offer appropriate medicines to children and thereby save millions of lives.


2012 ◽  
Vol 29 (2) ◽  
pp. 299-304 ◽  
Author(s):  
Xianting Ding ◽  
Hongquan Xu ◽  
Chanelle Hopper ◽  
Jian Yang ◽  
Chih-Ming Ho

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