Table 2.

Limitations to the Performance of Pharmacokinetic Studies in Infants and Children

Perception of ethical conflicts
 Requires diligence in safeguarding pediatric patients
Colleague ignorance of need for pediatric pharmacokinetic data
 Underestimating value for dose projections, particularly age-  disease-related
Analytical
 Small sample volume requirement
 Sensitivity/precision constraints
 Number of samples needed to define drug disposition profile  accurately