Figure 3. . Therapeutic orphans.

The pediatric community remains from several years to decades behind the adult population in terms of drug development. As a result, children are disproportionately treated with older, less modern drugs. Over 40 years ago, Shirkey recognized the dilemma of pediatric drug labeling, called therapeutic orphans, to capture its concept. There are many hurdles to overcome in conducting a pediatric versus an adult study. Available blood volumes for testing in particular are limiting. Accelerator mass spectrometry sensitivity allows accurate and precise determination of drug product in small microliter blood volumes [57].