Limited sampling model for the estimation of pharmacokinetic parameters in children.
A limited sampling model (LSM) is proposed for the first-time assessment of pharmacokinetic parameters (area under the concentration-time curve (AUC), Cmax, and T1/2) in children after a single oral dose of drug. Three drugs were evaluated in this study. The LSM was developed for each drug from the data of 10 healthy adult volunteers. The relationship at selected time points between plasma concentration and the AUC or Cmax was evaluated by multiple linear regression. The multiple linear regression that gave the best correlation coefficient (r) for 3 sampling times versus AUC or Cmax was chosen as the LSM. Pharmacokinetic parameters generated using sparse sampling (3 blood samples) were compared with pharmacokinetic parameters generated using extensive sampling (>7 blood samples). The results indicated that a limited sampling model can be developed from adult data to estimate pharmacokinetic parameters in children with fair degree of accuracy.
Mahmood
I
I
Division of Pharmaceutical Evaluation I, Office of Clinical Pharmacology and Biopharmaceutics, Food & Drug Administration, Rockville, MD 20852, USA.
D000284:Administration, Oral; D000328:Adult; D019540:Area Under Curve; D002648:Child; D016903:Drug Monitoring / Q000706:statistics & numerical data*; D006801:Humans; D016014:Linear Models; D008954:Models, Biological; D010599:Pharmacokinetics; D012016:Reference Values