Comprehensive Approaches to Precision Dosing

Systemic exposure to a drug may be closely related to outcome as well as side effects, but it would be naïve to think that exposure is the only parameter that we should focus on optimizing. As previously mentioned, there are other ways a drug’s effect can be monitored and other parameters may modulate the relationship between systemic exposure and effect. Thus, an ideal precision dosing approach goes far beyond the use of TDM reference ranges, TDM software, or even PKPD software with population models and Bayesian forecasting. In reality, we need to be able to monitor, aggregate, and derive conclusions from thousands of data points, and continually adjust treatment recommendations as new data points are collected. This calls for machine learning and artificial intelligence approaches that have started to make their mark on some areas of medicine, although not yet in precision dosing. Current and future technology will make this a reality and help bridge the gap between clinical studies and real-world patient care.40