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Am J Ther. 2015 Mar-Apr;22(2):132-40. doi: 10.1097/MJT.0b013e318274df57.

Prediction of drug concentration-time profiles in children from adults: an allometric approach.

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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.


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.

[Indexed for MEDLINE]

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