title: Prediction of drug concentration-time profiles in children from adults: an allometric approach.
abstract: The main objective of this work was to evaluate 2 methods to predict concentration-time profiles of drugs in children (aged 5 years or older) from adult pharmacokinetic (PK) parameters. Five drugs from the literature were chosen for this study, and all these 5 drugs were described by a 2-compartment model in both adults and children. PK parameters (CL, Vc, Vss, and Vβ) were allometrically predicted in children from adults. PK constants such as A, B, α, and β were also predicted in children from adults as described in . Using predicted PK parameters and constants, concentration-time profiles of 5 drugs were predicted in children and compared with the observed profiles. Both methods of predictions provided fairly good prediction of concentration-time profiles in children. The predicted concentration-time profiles in children were comparable with the observed profiles and can be used to design first-in-children clinical trials.
authors.affiliation: 1Department of Hematology, Office of Blood Review & Research (OBRR), Center for Biologic Evaluation and Research, Food and Drug Administration, Rockville, MD; and 2Clinical Pharmacology and DMPK, MedImmune LLC, Gaithersburg, MD.
authors.forename: Iftekhar
authors.initials: I
authors.lastname: Mahmood
authors.forename: Kosalaram
authors.initials: K
authors.lastname: Goteti
mesh_terms: D000328:Adult; D000367:Age Factors; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D006801:Humans; D008954:Models, Biological; D004364:Pharmaceutical Preparations / Q000008:administration & dosage* / Q000378:metabolism; D010599:Pharmacokinetics
chemical_list: D004364:Pharmaceutical Preparations