Modeling and simulation in pediatric research and development

Abstract

Pediatric research and development is typically poorly funded in both academic and industrial settings creating greater incentive for optimized trial designs with high degree of technical success. Likewise, the application of modeling and simulation approaches is extremely valuable in the evaluation of pediatric trial design. Beyond bridging adult dose-exposure relationships, pediatric clinical trial simulation models must accommodate relevant developmental, maturational, and size relationships on both PK and PD expressions. Design considerations that address sample size per age strata, the probability of achieving adult exposureresponse targets, and assumptions regarding PD response vs. outcomes are especially valuable in the support of pediatric drug development and/or dosing guidance. © American Association of Pharmaceutical Scientists 2011.