Extrapolation of Drug Clearance in Children ≤ 2 Years of Age from Empirical Models Using Data from Children (> 2 Years) and Adults.

ABSTRACT:

Background

The application of modeling and simulation approaches in clinical pharmacology studies has gained momentum over the last 20 years.

Objectives

The objective of this study was to develop six empirical models from clearance data obtained from children aged > 2 years and adults to evaluate the suitability of the models to predict drug clearance in children aged ≤ 2 years (preterm, term, and infants).

Methods

Ten drugs were included in this study and administered intravenously: alfentanil, amikacin, busulfan, cefetamet, meperidine, oxycodone, propofol, sufentanil, theophylline, and tobramycin. These drugs were selected according to the availability of individual subjects' weight, age, and clearance data (concentration-time data for these drugs were not available

SUBMITTER: Mahmood I 

PROVIDER: S-EPMC7067721 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature