Pediatric PK/PD modeling and simulation techniques are cornerstones of pediatric drug development. As identified by the FDA as part of the “Critical Path Initiative,” poor dose and dose regimen selection is a frequent reason for trial failure. PK/PD modeling and simulation approaches are particularly useful when existing data is available to support either a full or partial extrapolation of data from other patient populations.
Pediatric PK/PD modeling and simulation is a rapidly-evolving science. Application of these strategies can have an enormous impact on the design of pediatric studies, providing insight and guidance on the rational selection of pediatric doses and dose regimens. Different modeling approaches are used to understand the relationships between drug exposure and response, which in turn are used to build predictive models to guide pediatric dosing.