ABSTRACT
The pediatric subject, representing the spectrum from prematurely born neonates
to adolescents, is characterized by dynamic processes of physical, physiological,
and psychosocial development. The influence of growth and maturation on a
drug’s pharmacokinetics (PK) and pharmacodynamics (PD) is as dynamic as
children themselves. Prior to the end of the last century, most drugs had not
been studied in children; therefore, there were no adequate age-defined dose rec-
ommendations in the labels. As a result, pediatricians had to use these drugs on a
trial-and-error basis, which often led to either overdose or underdose, causing
toxicity or ineffectiveness. In 1997, the U.S. Congress passed the Food and
Drug Administration Modernization Act (FDAMA), which encouraged pediatric
drug development by providing an incentive in the form of an additional six
months’ marketing exclusivity. We have now seen an unprecedented surge in
research activity related to pediatric drug testing and labeling. The key issue of
pediatric drug development is to determine how much data are required in
pediatrics for establishing appropriate dosage regimen, given that the safety
and efficacy of a drug is already established in adults.
