Population approaches in paediatrics

Abstract

Population pharmacokinetic (PK) approach is now often used to evaluate PK characteristics of a new compound during its clinical development. Recently, new legislation governing the development and authorization of medicines for use in children aged 0-17 years was introduced in the European Union. Among the strategies proposed in relation to clinical aspects, use of population PKs is stated. In this manuscript, comparison between standard PK and population PK methods will be briefly addressed to understand why the second is particularly adapted to perform PK studies in paediatrics. Then, specific patients' characteristics (covariates) in paediatrics will be presented. Examples of PK and PK-pharmacodynamic (PK-PD) studies will be finally given. The number of population PK studies published still exceeds largely those of PK-PD.