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A Typical Design Summative Case Analysis

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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 F fat , 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. Several values of F fat were investigated. In a typical pharmacokinetic study, high imprecision was observed for NFM parameter estimates over a range of scenarios. For example, in a scenario where the true value of F fat on clearance was 0. The implications for practice are that one could conclude that fat-free mass best describes the relationship of the pharmacokinetics with body size, while the true relationship was between fat-free mass and total body weight. Consequently, this could lead to incorrect extrapolation of pharmacokinetics to extreme body sizes.

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A Typical Design Summative Case Analysis

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A Typical Design Summative Case Analysis

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A Typical Design Summative Case Analysis

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