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Abstract:
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In pediatric drug development, when the disease progression and response to treatment under investigation are believed to be sufficiently similar between the adult and the pediatric populations of interest, but the pharmacokinetic (PK) exposure-response (E-R) in pediatric patients is inadequately defined, one strategy may be to first investigate whether a pharmacodynamic (PD) endpoint is linked to the clinical response in adults. Once a PD endpoint is established, this endpoint can be used to establish the similarity in pharmacokinetic/pharmacodynamic (PK/PD) relationship between the pediatric and adult population. Establishing such similarity can then potentially be used to obtain health authority approval for the drug in the pediatric population of interest. In this presentation, we will describe how to assess similarity of such E-R (PK/PD) curves by estimating the percentage differences between adult and pediatric E-R curves using either Bayesian or frequentist methodologies. The percentage differences are compared against a pre-specified objective criterion to determine whether two curves are similar or in what exposure range they are similar. An example will be presented.
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