Pediatric dose selection.
Selection of a drug dose in pediatrics is generally based on no or incomplete pharmacokinetic data. Traditionally, allometric, or scaling, techniques have been used; however, they have inherent limitations and may not make optimal use of the drug-specific clinical pharmacokinetic information that is available. Modeling is a tool that holds promise. The future challenge is to create a structured approach to determining pediatric doses for new therapeutic agents.
Abernethy
D R
DR
Office of Clinical Pharmacology, US Food and Drug Administration, Silver Spring, Maryland, USA. darrell.abernethy@fda.hhs.gov
Burckart
G J
GJ
D000367:Age Factors; D002648:Child; D004305:Dose-Response Relationship, Drug; D054796:Drug Dosage Calculations; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D010372:Pediatrics / Q000379:methods* / Q000639:trends; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*
D004364:Pharmaceutical Preparations