Comparative Bioavailability of Loracarbef Chewable Tablet vs. Oral Suspension in Children

Impact of developmental pharmacology on pediatric study design: Overcoming the challenges

“…Concentration-and AUC-ranging results, when fixed doses of a drug are given to a pediatric study population, are illustrated in Fig 6, with the use of recent data for loracarbef. 37 In these instances, the need to repeat classic dose-ranging studies (such as those performed during phase I studies in adults) can be obviated. Finally, when AUC data are used to determine ageappropriate drug doses, it must be recognized that the "assumptions" that underlie this technique are predicated on a priori knowledge of "target" drug exposure levels and the assumption that the disease state or drug-receptor interaction between pediatric and adult patients is sufficiently similar, that is, comparable.…”