Review of Methods in Population Pharmacokinetics

Abstract

There are many procedures for estimating pharmacokinetic parameters in a population of patients. Those reviewed here include two traditional methods: Standard Two-Stage (STS) and Iterative Two-Stage methods, and three direct population pharmacokinetic (PPK) methods: Naive Pooled Data, Mixed-Effects Models, and Nonparametric methods. The classical method of estimation is the Standard Two-Stage method; however, multiple samples are required for each individual, which may not be feasible in certain populations. Direct population pharmacokinetic methods have been developed to analyze data sets consisting of a small number of samples per patient, by pooling the data into one data set and analyzing them simultaneously. In general, the direct population methods perform as well as the traditional methods and possess several advantages over traditional methods.