Advancing Pediatric Drug Development

Translation from adults data trending idea

Community Member kudos icon + Community member
Briefly describe your research question :

The common approach to dose selection in pediatric population when only adults data is available is population PKPD (PBPK) modelling.

  1. If age and weight are not identified as covariates for the model, if the flat exposure-response curve is observed in adult population, if in vitro tests and biology theory claim that there are no effects of growth and maturation on the observed levels of PD-markers (or components of the model) – is that enough for the justification for the selection for the pediatric population the same dose as for the adult population?

  2. If the population PKPD (PBPK) modelling based on adults data is integrated in the pediatric dose selection/justification process what requirements does that impose, if any, on the variability of age and weight?

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Idea No. 128