Exposure-response modelling approaches for determining optimal dosing rules in children.

ABSTRACT: Within paediatric populations, there may be distinct age groups characterised by different exposure-response relationships. Several regulatory guidance documents have suggested general age groupings. However, it is not clear whether these categorisations will be suitable for all new medicines and in all disease areas. We consider two model-based approaches to quantify how exposure-response model parameters vary over a continuum of ages: Bayesian penalised B-splines and model-based recursive partitioning. We propose an approach for deriving an optimal dosing rule given an estimate of how exposure-response model parameters vary with age. Methods are initially developed for a linear exposure-response model. We perform a simulation study to systematically evaluate how well the various approach

SUBMITTER: Wadsworth I 

PROVIDER: S-EPMC7528535 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature