The Rational Basis for Personalized Treatment Using Concentration-Guided Dosing.

Abstract

Background: The purpose of the review is to explain and encourage the use of terminology that distinguishes between the steps of measurement and reporting of concentrations, interpretation of the measurements, and subsequent prediction of individualized doses. The principles of concentration-guided dosing (CGD) provide a rational basis for personalized dosing. Existing terminology such as therapeutic drug monitoring (TDM) or model-informed precision dosing (MIPD) may have multiple meanings or be imprecisely defined. A brief history of CGD reveals the evolution of more accurate terminology focused on using concentration observations to provide individual drug dose guidance to clinicians.

Methods: Relevant literature was identified using keyword searches such as "TDM," "therapeutic range," "individualized dosing," "target concentration intervention," "precision dosing," "MIPD," and "personalized dosing." Studies were included if they addressed the theoretical basis, clinical implementation, and/or effectiveness of CGD approaches. The findings were synthesized to underscore the relevance of a CGD approach in the context of clinical pharmacology.

Results: CGD is commonly implemented using either the therapeutic window approach (TWA) or the target concentration approach (TCA). The dosing approach is often not specified for TDM and MIPD. Clinicians, clinical pharmacologists, and pharmacists have typically been trained to view TWA as the gold standard for personalized dosing.

Conclusions: Although many clinicians are well-versed in dosing using TWA, understanding and awareness of the benefits of TCA are still lacking. TCA offers accurate, personalized treatment by guiding the clinical team to use an optimally effective and safe dose for each patient.