A comparison of two sparse sampling population pharmacokinetic approaches for the estimation of pharmacokinetic parameters in children.
OBJECTIVE
The objectives of this study were to assess pharmacokinetic parameters (clearance, volume and half-life) in children using sparse sampling population as well as Bayesian (post hoc) approach.


METHODS
Three drugs were selected for this study. Two sparse sampling methods (variable or fixed) using population and Bayesian approaches were used to assess pharmacokinetic parameters in children following a single oral dose. The initial estimates of the model parameters and inter- and intrasubject variability were obtained from the pharmacokinetic studies conducted in adults. The estimated pharmacokinetic parameters using sparse sampling (3 blood samples) were compared with the pharmacokinetic parameters obtained by extensive sampling (> or = 7 blood samples).


CONCLUSIONS
The results indicated that both variable and fixed sampling approaches could be used to estimate mean population as well as individual pharmacokinetic parameters in children with fair degree of accuracy. The methods described here can be used to assess either population or individual pharmacokinetic parameters in children, provided there is a prior knowledge of the pharmacokinetics of a drug in adult population.
Mahmood
I
I
Division of Pharmaceutical Evaluation I, Office of Clinical Pharmacology and Biopharmaceutics (HFD-860), Food and Drug Administration, Woodmont Office Center II, Rockville, Pike, MD 20852, USA. Mahmoodi@CBER.FDA.GOV
Tammara
V
V
D000328:Adult; D019540:Area Under Curve; D001499:Bayes Theorem; D001800:Blood Specimen Collection / Q000379:methods*; D002648:Child; D002675:Child, Preschool; D006801:Humans; D008657:Metabolic Clearance Rate; D008954:Models, Biological; D010599:Pharmacokinetics; D012107:Research Design