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.
Office of Blood Review and Research, Center for Biologic Evaluation and Research, Food and Drug Administration, Rockville, MD.
Iftekhar
I
Mahmood
D002648:Child; D006207:Half-Life; D006801:Humans; D008954:Models, Biological; D010599:Pharmacokinetics; D015203:Reproducibility of Results; D018401:Sample Size; D014018:Tissue Distribution