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On some “disadvantages” of the population approach

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Abstract

In a seminal article on population pharmacokinetic modeling, researchers demonstrated how means and variances of pharmacokinetic parameters for a patient population could be inferred from sparse data collected under conditions of routine patient care. But they also identified 4 potential concerns about their methodology: unobserved confounding variables may bias the inferences; conditions under which data are collected may lead to inaccuracies of reporting or recording; correlations among important predictor variables may reduce statistical efficiency; and costs cannot be controlled by principles of study design. Experiences are reviewed that related to those potential disadvantages. A method is presented for diagnosing the possible presence of confounding. A model is constructed and applied that captures the influences of data inaccuracies. An example of selecting from among correlated covariates is summarized. Finally, a methodology for optimal study design is reviewed and applied to an example.

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Authors and Affiliations

  1. Biostatistics and Statistical Programming, Novartis Pharmaceuticals, One Health Plaza, 07936, East Hanover, NJ

    Jerry R. Nedelman PhD (Director)

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  1. Jerry R. Nedelman PhD
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Correspondence to Jerry R. Nedelman PhD.

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Published: October 5, 2005

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Nedelman, J.R. On some “disadvantages” of the population approach. AAPS J 7, 38 (2005). https://doi.org/10.1208/aapsj070238

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  • DOI: https://doi.org/10.1208/aapsj070238

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