Allometry Is a Reasonable Choice in Pediatric Drug Development.

Pharmacokinetics (PK) plays a key role in bridging drug efficacy and safety from adults to pediatric patients. The principal purpose of projecting dosing in pediatrics is to guide trial design, not to waive the study per se. This research was designed to evaluate whether the allometric scaling (AS) approach is a satisfactory method to design PK studies in pediatric patients aged 2 years and older. We systematically evaluated drugs that had pediatric label information updated from 1998 to 2015. Only intravenous (IV) or oral administration drugs with available PK information in both children and adults from FDA-approved labels were included. The allometric scaling approach was used to extrapolate adult clearance to pediatric clearance. The relative difference between the observed and the allometric scaling approach-predicted clearance was summarized and used to evaluate the predictive power of the allometric scaling approach. A total of 36 drugs eliminated by a metabolic pathway and 10 drugs by the renal pathway after intravenous (IV) or oral administration were included. Regardless of the administration route, elimination pathway, and age group, the allometric scaling approach can predict clearance in pediatric patients within a 2-fold difference; 18 of the included drugs were predicted within a 25% difference, and 31 drugs within a 50% difference. The allometric scaling approach can adequately design PK studies in pediatric subjects 2 years and older.