Scaling dose-exposure-response from adults to children

Abstract

For a paediatric development to be rationally informed by all available knowledge, it is necessary to systematically collect and learn from available data, expert knowledge and prior developments. Aspects such as drug formulation, bioanalytical methodology, pharmacokinetics/pharmacodynamics (PK/PD), study design and statistics should be considered when defining a development plan. In this context, model informed drug discovery and development (MID3) methodology [1] is likely to prove useful.