Because population PK/PD modeling is now being used virtually in every submission, specific therapeutic areas won’t necessarily benefit more from this approach. Instead, it may be simply easier to perform population PK/PD modeling within specific therapeutic areas.

In some instances, when the correlation between PK and efficacy and toxicity are very well known, such as in infectious diseases, PK/PD modeling is easier to perform. On the other hand, the mechanism of action of many drugs against neurological diseases such as Alzheimer’s disease may not be fully known. Biomarkers describing the potential efficacy are therefore more difficult to find. The true clinical end point may also take years to achieve. All these factors will add challenges to population PK/PD modeling.