[1][2] QSP can be viewed as a sub-discipline of pharmacometrics that focuses on modeling the mechanisms of drug pharmacokinetics (PK), pharmacodynamics (PD), and disease processes using a systems pharmacology point of view.
QSP can be used to generate biological/pharmacological hypotheses in silico to aid in the design of in vitro or in vivo non-clinical and clinical experiments.
[5] QSP emerged as a discipline through two workshops held at the National Institutes of Health (NIH) in 2008 and 2010, with the goal of merging of systems biology and pharmacology.
[2] A review of the history and future of QSP identified areas where it has advanced understanding of drug mechanisms, supported preclinical to clinical translation, and in general aided in drug development.
The FDA has included QSP as a component of the Model-Informed Drug Development Program.