Naive pooled-data approach for pharmacokinetic studies in pediatrics with a very small sample size.

The objective of this study was to evaluate if the pharmacokinetic (PK) parameters (clearance, volumes of distribution, and half-life) from 1 blood sample per subject using naive pooled data (NPD) analysis can be obtained with reasonable accuracy with a very small sample size (n = 5). For this study, 7 drugs were selected from the literature. The PKs of these 7 drugs were studied in pediatrics, and plasma concentrations versus time data for individual subjects from extensive blood sampling were available. For this analysis, only 5 subjects were chosen, and each subject gave 1 blood sample. The estimated PK parameters from NPD analysis were compared with the mean PK parameters obtained from extensive sampling. The result of the study indicated that a fairly accurate estimate of PK parameters can be obtained with 1 blood sample each from a minimum of 5 subjects using NPD analysis. The NPD analysis with sparse-sampling scheme can be useful for PK studies in neonates and very young children, where sample size is small.