title: Methods for pharmacokinetic analysis in young children.
abstract: BACKGROUND
  Pediatric physiology and disease states are often complex and are distinct from adults. Pediatric clinicians and scientists, as well as governmental regulators, are increasingly concerned with the necessity to optimize clinical pharmacological study design to achieve appropriate drug-dosing practices for various pediatric populations.
  
  
  METHODS
  There are significant challenges in clinical trial design, implementation and analysis that are unique to pediatric populations. Innovative techniques of sample preparation and analysis of pharmacokinetic (PK) studies as well as modern methods of data analysis, including PK modeling and simulation, that address some of these challenges are reviewed along with recent examples from the literature.
  
  
  CONCLUSIONS
  There have been clear and exciting advances in the understanding of pediatric clinical pharmacology in the areas of clinical trial design and sample analysis, as well as PK and pharmacodynamic modeling and simulation. Further advances require collaboration and interdisciplinary efforts from multiple specialties in both academia and industry. Ideally, these efforts will then not only provide informed and individualized dosing for pediatric patients but will also provide new methods and algorithms for broader use of new pharmacotherapeutic agents or applications.
authors: The Children's Hospital of Philadelphia, Division of Critical Care Medicine, Department of Anesthesiology and Critical Care Medicine , Main Building, Suite 7C26, 34th Street and Civic Center Blvd, Philadelphia, PA 19104 , USA zuppa@email.chop.edu.
authors: Adam S
authors: AS
authors: Himebauch
authors: Athena
authors: A
authors: Zuppa
mesh_terms: D002648:Child; D002675:Child, Preschool; D006801:Humans; D007223:Infant; D008954:Models, Biological; D010599:Pharmacokinetics; D012107:Research Design; D013223:Statistics as Topic