A Critique of Pharmacokinetic Calculators for Drug Dosing Individualization.

The 'one-dose-fits-all' approach where drug dosing regimen is prescribed according to recommendations from a summary of product characteristics is not appropriate for many patients whose clinical characteristics significantly differ from the most frequent ones in a population, as it cannot guarantee optimal exposure of target tissues to the drug. Our aim here is to provide a concise review of pharmacokinetic calculators currently available for clinical use and, at the same time, to suggest the minimum standards that they should satisfy to be routinely used in clinical practice. A systematic search of Medline, Ebsco, Scopus, Scindeks, Cochrane Library and Google Scholar was performed to find publications about available pharmacokinetic calculators for drug dose individualization. Theoretically well-founded and mathematically correct calculators for many drugs are available, but only a few calculators for specific drugs have been validated in clinical practice or through clinical trials, and the results published in peer-reviewed journals. The majority of available pharmacokinetic calculators for drug dosing individualization remain unvalidated, i.e., there is no evidence of their efficacy and safety in real-life clinical settings. Pharmacokinetic calculators for drug dose individualization are irreplaceable tools for achieving precision medicine, where dosing regimens are tailored to the needs and personal characteristics of each patient, maximizing efficacy and minimizing toxicity.