English Abstract Both in the development of medicinal products as well
as in risk assessment of other xenobiotics there is an increasing awareness
that children should be considered as a special group. Children are exposed
to other doses than adults and the pharmacokinetics and pharmacodynamics can
be very different in children and adults. In general it can be concluded
that the effects of age on pharmacokinetics are most pronounced during the
first 6-12 months of life. Full adjustment of dosing or TDI's for
pharmacokinetic differences can relatively easily be applied and should, to
our opinion be seen as a first step in considering risk for the paediatric
population. For risk assessment for drugs as well as for other xenobiotics,
it seems to be essential that young animal models will be used for
determining NOAELs, that are relevant for the paediatric population. The
use of a paediatric PBPK model possibly combined with pharmacodynamics
(PBPK/PD model) may be a valuable aid in risk
assessment.
