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ABSTRACT: Purpose
An influential covariate for pharmacokinetics is (body) size. Recently, the method of estimation of normal fat mass (NFM) has been advocated. Here, the relative contribution of fat mass, estimated as a fraction fat (Ffat), is used to explain differences in pharmacokinetic parameters. This concept is more and more applied. However, it remains unclear whether NFM can be reliably estimated in these typical studies.Methods
We performed an evaluation of the reliability of NFM estimation in a typical study size (n = 30), otherwise best-case scenario, by means of a pharmacokinetic simulation study. Several values of Ffat were investigated.Results
In a typical pharmacokinetic study, high imprecision was observed for NFM parameter estimates over a range of scenarios.
SUBMITTER: Wasmann RE
PROVIDER: S-EPMC8032617 | biostudies-literature | 2021 May
REPOSITORIES: biostudies-literature