Precision dosing aims to tailor drug doses to the characteristics and needs of an individual patient. One of the most common precision dosing approaches that doctors use is therapeutic drug monitoring (TDM), in which drug concentrations are measured in a person's blood and interpreted alongside how the person is responding to the drug (for example, how their organs are functioning). TDM helps doctors adjust dosing to ensure the person is receiving the optimal dose to manage their medical condition while minimizing toxicity.
Model-informed precision dosing (MIPD) combines data specific to the individual patient with models of how the medication enters, is distributed, and is broken down in the body, to guide doctors in individualized dosing decisions. MIPD may incorporate information such as age, weight, laboratory values, genetic factors, organ function, medications already being taken, and measured drug concentrations. By integrating these data, MIPD can predict a recommended dose for an individual patient. MIPD is being used to optimize dosing of medications such as antimicrobials, immunosuppressants, anticoagulants, and cancer therapies.
Physiologically-based pharmacokinetic (PBPK) modeling is a specialized approach that contributes to precision dosing and is used primarily in research and drug development. PBPK models integrate detailed information about human physiology, disease states, and properties of different medications to simulate how a medication may be absorbed, distributed, metabolized, and eliminated in different individuals or populations. These models can help predict how a drug will work in a specific individual when clinical data are limited and can give doctors dosing recommendations for populations that are difficult to study directly.
Artificial intelligence (AI) and machine learning (ML) have accelerated the development and application of both PBPK and MIPD approaches. However, further research is needed to make certain these AI and ML approaches are safe and reliable in different patient populations before they can be routinely incorporated into clinical care.
Precision dosing strategies are especially valuable for populations that are often underrepresented in clinical trials who may have different responses to drugs than the general population, and therefore may not be optimally managed with standard dosing recommendations. These populations include newborns and children, older adults, pregnant people, and individuals with severe kidney or liver impairment. Individualized dosing approaches can improve treatment effectiveness, reduce adverse drug reactions, and advance the goal of safer, more equitable, and more personalized patient care.
