title: A Bayesian approach for the estimation of pharmacokinetic parameters in children.
abstract: A Bayesian method is proposed for the first-time assessment of pharmacokinetic parameters (area under the curve [AUC], maximum concentration [C(max)], half-life [T(1/2)]) in children after a single oral dose. Pharmacokinetic parameters were compared using sparse sampling (three blood samples) with extensive sampling (nine blood samples). Two different therapeutic classes of drugs were evaluated in this study. The population pharmacokinetic parameters and the blood sampling time points were obtained from adult data. The results indicate that the Bayesian approach can be used to estimate pharmacokinetic parameters in children with fair degree of accuracy. The Bayesian method described here can be used to assess pharmacokinetic parameters in children, provided there is a prior knowledge of the pharmacokinetics of a drug in adult population.
authors.affiliation: Division of Pharmaceutical Evaluation I, Office of Clinical Pharmacology and Biopharmaceutics, Food and Drug Administration, Woodmont Office Center I, Suite 200N, 1401 Rockville Pike, Rockville, MD 20852, USA. Mahmoodi@cber.fda.gov
authors.forename: Iftekhar
authors.initials: I
authors.lastname: Mahmood
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D019540:Area Under Curve; D001499:Bayes Theorem; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D005069:Evaluation Studies as Topic; D005260:Female; D006207:Half-Life; D006801:Humans; D008297:Male; D008962:Models, Theoretical; D010599:Pharmacokinetics; D018401:Sample Size