ArticlesLimited Sampling Model for the Estimation of Pharmacokinetic Parameters in ChildrenMahmood, IftekharAuthor Information Division of Pharmaceutical Evaluation I. Office of Clinical Pharmacology and Biopharmaceutics, HFD-860. Food & Drug Administration., Woodmont Office Center II, 1451 Rockville Pike, Rockville, MD 20852. Received March 3, 2000; accepted July 5, 2000. Address correspondence and reprint requests to Iftekhar Mahmood, Ph.D., Division of Pharmaceutical Evaluation I, Office of Clinical Pharmacology and Biopharmaceutics, HFD-860, Food & Drug Administration, Woodmont Office Center II, 1451 Rockville Pike, Rockville, MD 20852. The views expressed in this article are those of the author and do not reflect the official policy of the FDA. No official support or endorsement by the FDA is intended or should be inferred. Therapeutic Drug Monitoring: October 2000 - Volume 22 - Issue 5 - p 532-536 Buy Abstract A limited sampling model (LSM) is proposed for the first-time assessment of pharmacokinetic parameters (area under the concentration–time curve (AUC), Cmax, and T½) 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. © 2000 Lippincott Williams & Wilkins, Inc.