By Development, and Translation Forum on Drug Discovery, Institute of Medicine
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Extra info for Addressing the Barriers to Pediatric Drug Development: Workshop Summary
Etodolac (Lodine), used for symptom relief in juvenile rheumatoid arthritis, underwent labeling changes after studies showed that patients aged 6 to 16 years required a higher dose (on a per-kilogram basis) than expected—approximately twice the lower dose recommended for effective treatment in adults. • Labeling changes were made to fluvoxamine (Luvox), a treatment for obsessive-compulsive disorder, to recommend higher doses in adolescents than were previously indicated, with the exception of girls aged 8 to 11, who may require lower doses because the drug can make them drowsy.
The formulation of a drug needs to be different for younger and older patients. • The expertise needed for pediatric trials often is not available in house, so external experts need to be consulted. SOURCE: Jarrett, 2006. 26 ADDRESSING THE BARRIERS TO PEDIATRIC DRUG DEVELOPMENT tees. ������������������������������������������������������������������� Regulatory agreements on protocols or Written Requests can require many rounds of feedback and sometimes years to achieve, particularly if more than one health authority is involved.
If such studies exist, they are frequently based on very small, selected populations. Dr. Ward gave a neonatologist’s perspective on treating newborns, whom he views as the most susceptible pediatric patients. He provided several examples of how pharmacokinetics and organ function (such as that of the heart and the kidneys) vary in important ways among a 23-week premature infant, a 30-week premature infant, and a 40-week full-term infant. He also cited studies that have revealed ethnic variations in the distribution of certain enzymes that cause faster or slower metabolism of drugs.
Addressing the Barriers to Pediatric Drug Development: Workshop Summary by Development, and Translation Forum on Drug Discovery, Institute of Medicine