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NONMEM: AN ALTERNATIVE TO TRADITIONAL PHARMACOKINETIC STUDIES IN PEDIATRIC POPULATIONS

Traditional pharmacokinetic studies provide valuable information for optimizing the clinical use of pharmacologic agents. These studies generally require careful and extensive sampling of blood from subjects to determine pharmacokinetic parameters, making them less useful and less feasible in pediatric practice. As a result, data from adult patients or volunteers are often erroneously extrapolated for pediatric use.Sheiner et al (J Pharmacokin Biopharm 5:445,1977) developed a computer program, NONMEM, to estimate population pharmacokinetic parameters from data generated during routine clinical care of patients. NONMEM uses the method of extended least squares and allows for pooling of data from many individuals, but explicitly adjusts for the correlation of data obtained from each individual. NONMEM's advantage is that it can be utilized when only a few blood samples are available from each patient, provided the overall size of the study population is large. Thus, NONMEM is an ideal method for estimating population pharmacokinetic parameters in the newborn and general pediatric populations, where the frequency and volume of sampling are important considerations. This will provide the capability to accurately determine population pharmacokinetic parameters for a number of potentially toxic drugs with which newborns and children are treated.