Abstract
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.
Original language | Undefined/Unknown |
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Pages (from-to) | 316-320 |
Number of pages | 5 |
Journal | Drug Discovery Today |
Volume | 14 |
Issue number | 5-6 |
DOIs | |
Publication status | Published - 2009 |
Research programs
- EMC MGC-02-53-01-A
- EMC OR-02-54-06