Does size matter? : bridging and dose selection in paediatric trials Cella, M.

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In conclusion, meta-analysis of rich adult data and sparse paediatric data using non-linear mixed effects modelling offers the possibility to detect differences in

Using data from six pharmacokinetic studies in adults and one study in children, a model- based analysis was applied to characterise differences in parameter distributions and

With this in mind, the lower exposure in infants and toddlers would suggest the need for an adjustment of the dosing regimen: using a model built on children data the target

To evaluate the predictive power of a model-based approach to characterise the exposure to midazolam in a different paediatric population, the parameter estimates from the model

In this paper we look at the implications of another commonly used assumption for the selection of the paediatric dose, i.e., that the same ratio between two (or more) drugs in a

In addition to the target exposure, a comparison was performed of the precision and accuracy of model parameter estimates obtained from data generated according to a fixed dose

The dose rationale for drug combinations in children should therefore be based on exposure ratios rather than dose ratios.. This prerequisite has important consequences for the