Rational dosing guidelines for drugs in pediatrics are urgently needed. To develop these guidelines, we use population pharmacokinetic-pharmacodynamic (PK-PD) modeling and simulation by: (i) optimization of clinical trial designs based on preliminary data; (ii) development and internal validation of population PK-PD models using sparse data; (iii) external validation using independent data; and (iv) prospective clinical evaluation. Optimized dosing regimens for specific drugs may then serve as a basis to develop dosing guidelines for existing or newly developed drugs with similar disposition and/or effect. In addition to modeling of drug disposition (PK) pathways, we emphasize the need for modeling of effect (PD) pathways and the use of a multidisciplinary infrastructure for data-sharing.

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Persistent URL dx.doi.org/10.1016/j.drudis.2008.11.004, hdl.handle.net/1765/26993
Journal Drug Discovery Today
Ince, I, de Wildt, S.N, Tibboel, D, Danhof, M, & Knibbe, C.A.J. (2009). Tailor-made drug treatment for children. Creation of an infrastructure for data-sharing and population PK-PD modeling. Drug Discovery Today (Vol. 14, pp. 316–320). doi:10.1016/j.drudis.2008.11.004